Monday report

Rx coverage

Monday report

David Ermer–CDC, Electronic health records, FDA, HIPAA Privacy and Security Rules, Medical / Rx research, Rx coverage, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • The Washington Post reports,
    • “President Donald Trump on Monday announced that about 600 low-cost generic drugs would be available through TrumpRx.gov, a government website aimed at helping Americans purchase medications at discounted prices. 
    • “By incorporating this massive catalog of low-cost generics at TrumpRx.gov, consumers will now have one source to ensure that they’re getting the lowest possible cost on their prescription,” Trump said in a presentation at the Eisenhower Executive Office Building.”
  • Federal News Network relates
    • “HHS sends RIF notices to dozens of staff it missed during office-wide layoffs last year.
    • “Meanwhile, HHS is looking to convert hundreds of senior positions to a rebranded version of the “Schedule F” classification for federal employees.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced a reorganization of its Office for Civil Rights (OCR), the Department’s law enforcement agency charged with enforcing laws protecting civil rights, conscience and religious freedom, and health information privacy and security. The reorganization returns OCR to a program-based structure that aligns OCR’s three critical substantive areas with three distinct subject-matter divisions: the Conscience and Religious Freedom Division, the Civil Rights Division, and the Health Information Privacy, Data, and Cybersecurity Division.
    • “This reorganization restores the HHS Civil Rights Division and the Conscience and Religious Freedom Division and strengthens the Office for Civil Rights’ ability to defend religious liberty, enforce conscience protections, and combat unlawful discrimination,” said Health and Human Services Secretary Robert F. Kennedy, Jr. “Under President Trump’s leadership, HHS will defend these rights with clarity, accountability, and resolve.”
    • “This reorganization reinstitutes a structure that rightly prioritizes civil rights and conscience and religious freedom alongside health information privacy and security,” said HHS Office for Civil Rights Director Paula M. Stannard. “All three areas are deserving of subject-matter expertise and distinct senior executive leadership for OCR to best serve the American people.”
  • The American Hospital Association News adds,
    • “Most hospital outreach laboratories must report private payer clinical diagnostic laboratory data for services furnished during the first six months of 2025 to the Centers for Medicare & Medicaid Services by July 31, the agency announced. This includes Healthcare Common Procedure Coding System codes, associated private payer rates and volume data. CMS previously sent letters to hospitals, which the agency believes have outreach laboratories that are likely required to report their data. CMS also has a guide and other resources for hospital outreach laboratories to determine whether and how they must report.” 

From the Food and Drug Administration,

  • The Wall Street Journal reports,
    • “AstraZeneca AZN said it received U.S. approval for a new hypertension treatment, getting the green light to launch a drug the U.K. pharmaceutical company expects to generate multibillion-dollar annual sales at its peak.
    • “The drug, known until now as baxdrostat, will be marketed under the brand name Baxfendy, the company said Monday. The approval expands AstraZeneca’s cardiovascular, renal and metabolism portfolio shortly after diabetes drug Farxiga—its biggest product in that therapeutic area and the bestselling medicine in the company’s history—went off patent in the U.S.
    • “AstraZeneca said that Baxfendy treats hypertension in a new way by targeting aldosterone, a hormone that raises blood pressure.
    • “Ruud Dobber, executive vice president of AstraZeneca’s biopharmaceuticals business, said the approval brings a new treatment to a disease that has had little therapeutic progress for the past two decades.”
  • Fierce Pharma relates,
    • “Enhertu’s market conquest is continuing apace. Already tracking at $5 billion in annual sales, the star antibody-drug conjugate from Daiichi Sankyo and AstraZeneca has secured FDA approval to treat early breast cancer, further encroaching on Roche’s Kadcyla territory.
    • “The FDA has simultaneously greenlighted Enhertu for both the neoadjuvant and adjuvant treatment of patients with HER2-positive early breast cancer, the two companies said Friday [July 15, 2026]. The adjuvant nod came nearly two months ahead of schedule, as the FDA had originally targeted a decision by July 7.”
  • The New York Times tells us,
    • “A California dairy company has issued a recall for five ice cream flavors, warning customers that some tubs may be contaminated with metal.
    • “The company, Straus Family Creamery, recalled some of its organic ice cream, which was sold in 17 states since May 4. It said it ordered the recall because of “the potential presence of metal foreign material,” without giving further details.
    • “The warning applies to its vanilla bean, strawberry, cookie dough, Dutch chocolate and mint chip flavors with specific “best-by” dates in late December 2026.
    • “It did not say how many tubs were affected but said the issue was with a “small number of production runs.”
  • Health Day informs us,
    • “The U.S. Food and Drug Administration (FDA) has approved an AI-powered early warning system to detect sepsis, one of the deadliest infections for hospital patients.
    • “The tool, developed at Johns Hopkins University (JHU), detects sepsis hours faster than doctors. It has already reduced deaths by nearly 20% in dozens of hospitals across the United States, JHU reports.
    • “Pre-suspicion screening is what creates lead time, and lead time is what changes outcomes in sepsis,” said Suchi Saria, director of JHU’s AI & Healthcare Lab. “Once a clinician already suspects sepsis, the clock has been running — often for hours or even days.”

From the judicial front,

  • Bloomberg Law reports,
    • “The US Supreme Court turned away appeals from six pharmaceutical companies seeking to topple the Medicare drug price negotiation program that’s led to billions of dollars in discounts on top-selling treatments.
    • “Making no comment, the justices on Monday refused to hear a variety of constitutional arguments against a program created in 2022 by President Joe Biden’s Inflation Reduction Act. The court rejected separate appeals from units of AstraZeneca Plc, Johnson & Johnson, Bristol Myers Squibb Co., Novartis AG, Novo Nordisk A/S and Boehringer Ingelheim Pharmaceuticals Inc.
    • “The rebuffs leave in force a program the US government said in November will produce a 71% discount on Novo Nordisk’s blockbuster Ozempic and Wegovy drugs for Medicare patients starting in 2027. The Trump administration said that round of discounts, covering 15 drugs, will mean $12 billion in savings compared with 2024 list prices.
    • “The cases at the high court involved the previous year’s negotiated discounts, which covered 10 drugs and took effect in January. The Centers for Medicare and Medicaid Services said in 2024 that the deals would reduce out-of-pocket costs by $1.5 billion this year.”
  • Per a Justice Department news release,
    • “A New York man was sentenced today to 37 months in prison for conspiring to launder nearly $1.5 million in illicit health care fraud proceeds through multiple domestic and global banks on behalf of a Transnational Criminal Organization (Organization).
    • “According to court documents, Elnar Zarbailov, 42, of Staten Island, New York, and dual citizen of the United States and Azerbaijan, was a fixer and money launderer for the foreign-based  Organization that spearheaded the largest health care fraud case ever prosecuted by the Department of Justice, as uncovered by Operation Gold Rush. The Organization, based in Russia and elsewhere, orchestrated a multi-billion-dollar health care fraud and money laundering scheme to target, exploit, and steal from Medicare and private health insurance companies.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “The CDC announced Monday that an American tested positive for Ebola this weekend while working in Congo and is being transported to Germany for treatment along with six other Americans who are high-risk contacts. 
    • “The Centers for Disease Control and Prevention also is enhancing public health screening and traveler monitoring amid a growing Ebola outbreak, and non-U.S. passport holders face entry restrictions if they have been to Uganda, the Democratic Republic of Congo or South Sudan in the previous 21 days.
    • “To the American public, the risk to the United States remains low,” said Satish Pillai, CDC Ebola response incident manager. “Travelers to the region should avoid contact with sick people, report symptoms immediately, and follow our travel guidance.”
  • Health Exec points out,
    • “A healthcare research firm that provides trend analysis to stakeholders released a new report that examined usage of behavioral health services post-COVID, showing that demand and utilization for mental healthcare and addiction mitigation have intensified since the pandemic.
    • “According to the data from Trilliant Health, while the utilization of care related to emotional health, mental health, autism, and alcohol and drug dependency stand at new highs since the COVID lockdowns, outcomes may not be improving.
    • “Using publicly available data on utilization, provider numbers and demand, Trilliant’s data paints a picture of a mental healthcare system that is overburdened. From 2018 to 2024, the group reports that the number of behavioral health visits jumped 62.6%, standing at 1,346 visits per 1,000 people.
    • “People seeking care for anxiety led the trend, accounting for 89.3% of growth. Women aged 18-44 made up the majority of that cohort. However, Trilliant noted that childhood developmental disorders—autism, attention deficit disorder, speech problems and other issues including anxiety—including attempted self-harm, have risen nearly 48% over 20 years, from 2004-2024.”
  • Health Day adds,
    • Many older adults see cannabis as a more effective or nonpharmaceutical option to manage sleep, pain, or mental health, according to a study published online May 8 in JAMA Network Open.
    • Rebecca K. Delaney, Ph.D., from the University of Utah Intermountain Health Department of Population Health Sciences in Salt Lake City, and colleagues explored the motivations of older adults in Colorado interested in purchasing edible cannabis products to improve sleep, pain, or mental health concerns, as well as the perceived benefits and drawbacks of different cannabinoid profiles. The analysis included 169 interview participants aged 60 years and older.
  • The New York Times relates,
    • “A study of insurance claims for 1.8 million children found that the number of families raising mental health issues at visits to general practitioners rose sharply over a decade, with anxiety by far the fastest-growing complaint.
    • “The study, which was published on Monday in the journal JAMA Network Open, found that the number of pediatric visits rose to 9.7 percent in 2023 from 5.7 percent in 2014.
    • “The study included all insurance claims for children from ages 1 to 18 in Massachusetts, for a total of more than 1.8 million children. Visits were counted as mental health visits if a diagnostic code was included in the claim, either because the child or the family raised the issue or because the child screened positive for mental health symptoms during the visit.
    • “Visits for anxiety rose by more than 250 percent during that period, to 6.1 percent in 2023 from 1.7 percent in 2014.”
  • The American Medical Association lets us know “nine things patients should know about taking creatine.”
    • “The ‘Health vs. Hype’ AMA podcast explores what creatine is, its association with bodybuilders, and whether it’s safe for the general public.”
  • Medpage Today tells us,
    • “A course of azithromycin for preschoolers who presented to the emergency department (ED) with wheezing didn’t improve their symptoms, the AZ-SWED trial showed.
    • :Among children, ages 18-59 months, the 5-day sum of scores on the Asthma Flare-up Diary for Young Children (ADYC) did not differ significantly compared with placebo in either those who initially tested positive for pathogenic bacteria (median 9.59 vs 9.72, P=0.70) or those who tested negative (9.30 vs 9.10, P=0.69). ADYC scores range from 5-35 points, with higher scores indicating more severe symptoms.
    • “While the trial was stopped early for futility — reducing the statistical power of the trial — it was sufficient to show that “a moderate or large true effect is implausible,” Richard M. Ruddy, MD, of the University of Cincinnati College of Medicine, reported at the American Thoracic Societyannual meeting in Orlando. The findings were published simultaneously in the New England Journal of Medicine.”
  • and
    • “The 2025/2026 seasonal COVID vaccination was associated with a roughly 50% reduced risk for illness up to 9 weeks post-vaccination, especially in older Canadian adults, according to an interim analysis by the Canadian Sentinel Practitioner Surveillance Network. The seasonal vaccine, which was specifically formulated to target the LP.8.1 variant, also appeared to offer protection from other strains.
    • “An important aspect of the 2025/2026 season was the simultaneous circulation of influenza and other respiratory viruses, which suggested the need to consider the role that respiratory virus co-circulation might play in estimating vaccine effectiveness (VE).
    • “This year, we were especially interested to check the effects of co-circulating respiratory viruses (eg, influenza and respiratory syncytial virus [RSV]) since COVID circulated at only low levels through the current season,” lead author Danuta M. Skowronski, MD, epidemiology lead for influenza and emerging respiratory pathogens at the BC Centre for Disease Control in Vancouver, told Medscape News Canada.”
  • The American Journal of Managed Care points out,
    • “A retrospective VA cohort (2006–2019) compared ≥75-year-olds with adenoma vs no adenoma at ages 65–75 using registry and National Death Index outcomes. 
    • “Ten-year CRC incidence and CRC death were statistically higher with prior adenoma, but absolute differences were small and clinically overshadowed by competing non-CRC mortality. 
    • “Frailty stratification showed progressively lower CRC incidence and sharply higher non-CRC death, with severe frailty demonstrating <1% CRC versus 82% non-CRC death. 
    • “Advanced adenoma status did not significantly alter CRC risk, and follow-up colonoscopy rates after 75 were not higher among patients later developing CRC. 
    • “Generalizability is limited by a 98% male veteran population, reinforcing the need for confirmatory analyses in cohorts with greater female representation.”
  • Per BioPharma Dive
    • “An experimental cancer immunotherapy from Regeneron failed a late-stage study in melanoma in a surprise setback for the big biotechnology company’s oncology business.
    • “A regimen involving the prospect, fianlimab, and Regeneron’s marketed medicine Libtayo didn’t significantly delay cancer progression compared to Merck & Co.’s Keytruda in patients with unresectable metastatic melanoma. A high-dose combination held tumors in check for a median of 11.5 months, compared to 6.4 months for Keytruda recipients, a difference that narrowly missed statistical significance.
    • “Regeneron didn’t provide additional details but will present them at a future medical meeting. Another Phase 3 study testing fianlimab against Opdualag, a similar cancer immunotherapy sold by Bristol Myers Squibb, is ongoing. Company shares fell by double digits early Monday, erasing billions of dollars in market value.”

From the U.S. healthcare business front

  • Kauffman Hall reports,
    • Key Takeaways
      • March was the best month for hospitals in 2026 so far, despite mixed volumes. Month-over month discharges rose while patient days fell, indicating increased focus on improving average length of stay and a continued shift to outpatient care.
      • Operating margins improved month-over-month but remain below 2025. While bad debt and charity care declined month-over-month, gross revenue continues to outpace net, highlighting eroding payor mix.
      • Expenses declined in March, yet remain elevated year-over-year. Favorable improvements across the board are likely correlated to the decrease in average length of stay. However, drug expenses remain a primary driver of expense growth year-to-date.
      • Two notable outliers emerged in otherwise steady regional trends. The Northeast saw margin improvement, despite historical underperformance, while the West experienced the most dramatic increase in drug expense.
    • To view more insights on trends affecting hospitals and steps you can consider taking to address them, download the latest issue of the National Hospital Flash Report.
  • Beckers Payer Issues notes,
    • “Blue Cross and Blue Shield of Massachusetts reported a net income of $59.6 million in the first quarter of 2026, a return to profitability after back-to-back annual losses in 2024 and 2025.
    • “The insurer posted revenue of $2.6 billion in the first quarter, reflecting a 2% net margin. Operating and other income came in at $17.4 million (0.6% operating margin), with investment income contributing $42.2 million.
    • “The company attributed the improved results to disciplined cost management, a milder-than-expected flu season and changes to its coverage of GLP-1 medications.
    • “Our first-quarter results reflect the challenging but necessary actions we’ve taken over the past year, including pricing our benefit plans to their true cost, identifying medical and pharmacy spending that doesn’t add value for our members, and keeping rate increases to our provider network at or below the state benchmark,” CFO Ruby Kam said May 15.”
  • Fierce Healthcare relates,
    • “Now three quarters into its fiscal year, Ascension has chopped down its operating losses by more than half and more than tripled its bottom-line gain. 
    • “The nonprofit system reported Friday a $203 million operating loss (-1.1% operating margin) for the nine months ended March 31, 2026, improving on the $466 million operating loss (-2.3%) for the prior fiscal year. 
    • “Both its total operating revenue and operating expenses dipped from the prior year due to a slew of divestitures. The former declined by 7.2% to $18.1 billion while the latter fell by 8.1% to $18.3 billion; on a same-facility basis, total operating revenue grew 9.3% while expenses increased 5.7%.” 
  • Healthcare IT News explains “How one practice combines in-clinic, telehealth and in-home care.”
    • “Dr. Payam Zamani is a practicing family medicine physician and founder and CEO of My Dr Now, one of the largest primary care providers in the Southwest. It’s designed as a hybrid in-person/telehealth/in-home health system.”
    • “When patients engage earlier and follow through consistently, the health system operates more efficiently, My Dr Now’s physician CEO reports: “This is not about technology for its own sake, it’s about designing care delivery around real life.”
  • Modern Healthcare tells us,
    • “Oregon gave the green light for Compassus to acquire a 50% stake in Providence’s home health and hospice operations across the state.
    • “After more than a year of review, Oregon Health Authority’s Health Care Market Oversight program said in a Friday news release it approved the joint venture with conditions.
    • “The Oregon deal is expected to close in the fall, Providence said in an email.”
  • and
    • “RWJBarnabas Health has opened a $7 million food-is-medicine hub to take on chronic disease, making it a potential standard bearer in the Make America Healthy Again movement.
    • “Last week, the New Jersey academic health system opened Harvest — an 8,000-square-foot facility in Newark that is a combination food bank, commercial kitchen and classroom. The center is designed to teach people living in nearby food deserts how to eat healthier and provide them with the food to do it.”
  • Health System CIO informs us,
    • “Epic added 77 acute care hospitals in 2025 while Oracle Health shed 56, according to the new KLAS report, “US Acute Care EHR Market Share 2026.” The five-year picture is even starker. Epic has gained a net 568 hospitals since 2021 while Oracle Health has lost 173. In total, the report covers EHR contracts executed from January through December 2025. Epic now holds 43.7% of acute care hospital market share and 56.9% of beds. Oracle Health, meanwhile, sits second at 21.9% of hospitals and 20.4% of beds, followed by Meditech at 14.7% and 12.5%.” * * *
    • “Hospitals impacted by EHR decisions fell about 40% from 2024 as buyers shifted investment toward AI and operational efficiency tools.”
  • Per MedTech Dive,
    • “Boston Scientific said Monday it has invested $1.5 billion to acquire a 34% equity stake in MiRus, a company developing a balloon-expandable transcatheter aortic valve replacement system.
    • “The agreement gives Boston Scientific an exclusive option to acquire the MiRus TAVR system, subject to additional payments and the completion of certain clinical and regulatory milestones. Boston Scientific said it may opt to acquire the rest of the TAVR business for additional cash payments totaling $3 billion.
    • “The deal comes about a year after Boston Scientific stopped selling its Acurate Neo2 and Acurate Prime TAVR devices, which were CE-marked in Europe, and ended plans to pursue approvals in the U.S. and other locations.”

Weekend update

David Ermer–CMS, Congress, Federal employment benefits, Medicare, Rx coverage, SCOTUS, U.S. Healthcare–

From Washington, DC

  • Roll Call offers an overview of this week’s anticipated activities on Capitol Hill.
  • STAT News reports,
    • “Bill Cassidy, a key Republican health care leader in the Senate, will lose his seat, as Louisiana’s Senate primary heads for a runoff between state treasurer John Fleming and Rep. Julia Letlow, who won President Trump’s endorsement.” * * *
    • “Cassidy’s defeat is a win for President Trump and his allies, who have criticized the senator for voting in 2021 to convict the president for inciting the January 6 insurrection.” * * *
    • “Cassidy will likely remain chair of his committee until his term ends at the start of next year, potentially setting up roadblocks for Kennedy as he attempts to fill several vacancies across his department. That includes a new Food and Drug Administration commissioner, and nominees for surgeon general and Centers for Disease Control and Prevention director.”
  • Federal News Network points out four benefits bills in Congress for federal employees, retirees to watch. “Potential adjustments to short-term disability insurance and credit protection for feds during government shutdowns are on the table through new legislation.
  • Per a May 15, 2026, Centers for Medicare and Medicaid news release,
    • “The Centers for Medicare & Medicaid Services (CMS) issued a sweeping rule to strengthen oversight of the Affordable Care Act (ACA) Exchanges for plan year 2027 by lowering user fees, tightening eligibility verification, and giving states greater authority over plan oversight.
    • The final rule, “Notice of Benefit and Payment Parameters for 2027; Basic Health Program” (the 2027 Payment Notice final rule) reduces federal Exchange user fees to help lower premiums, establishes new safeguards to prevent improper enrollments, ensures subsidies go only to eligible individuals, increases consumer choice, affordability, access and protections, and expands state flexibility to manage Exchange operations.
    • “The rule strengthens program integrity, expands consumer protections, promotes plan innovation and consumer choice, and restores greater authority to states. 
    • “American taxpayers deserve to know their dollars are going only to people who truly qualify,” said CMS Administrator Dr. Mehmet Oz. “This rule strengthens eligibility checks, cracks down on abuse, and gives insurers more flexibility to offer affordable, consumer-focused coverage options.”
  • Here is a link to the CMS fact sheet on this final rule.
  • Kevin Moss writes in Govexec,
    • “CMS is launching the Medicare GLP-1 Bridge program, which will extend coverage of certain GLP-1 medications for weight loss to eligible Medicare beneficiaries, regardless of whether they have an underlying medical condition” effective July 1, 2026. 
    • “For [FEHB and PSHB} annuitants enrolled in Part D, this program could expand your options. Here’s [in the article] what it covers, who qualifies, and what it means for you.”
  • The U.S. Supreme Court will be releasing opinions at 10 am every Thursday morning until the end of next month.

From the public health and medical / Rx research front

  • The Wall Street Journal considers whether “the Weight-Loss Drug Revolution Causing a Frailty Epidemic? As millions flock to GLP-1s, doctors warn the drugs can cause rapid and significant muscle loss” and assesses “What Science Tells Us About the Risks of Hantavirus. Rare virus has high fatality rate and can spread through the air, research shows, though it is easier to contain than Covid-19.”
  • Health Day reports,
    • “A major women’s health condition is getting a new name—and experts say it could change how millions are diagnosed and treated worldwide.
    • “Polycystic ovary syndrome, or PCOS, will now be known as polyendocrine metabolic ovarian syndrome, or PMOS.
    • “The condition affects more than 170 million women worldwide and is linked to hormone imbalances, weight and metabolic issues, mental health symptoms, skin changes and fertility challenges.
    • “Experts said the old name was misleading because the condition is not actually defined by ovarian cysts.
    • “What we now know is that there is actually no increase in abnormal cysts on the ovary and the diverse features of the condition were often unappreciated,” said Helena Teede, director of the Monash Center for Health Research & Implementation in Australia and an endocrinologist at Monash Health.”
  • BioPharma Dive relates,
    • “A year after Vertex’s big launch, pain drug research faces a pivotal moment.
    • “Journavx started to revive area of development long considered a graveyard. Can any other pain drugs keep investor excitement going?”

From the U.S. healthcare business and artificial intelligence front,

  • The Wall Street Journal reports,
    • “Nurse practitioners and physician assistants are increasingly filling healthcare gaps, with NP ranks growing 60% to 461,000 between 2019 and 2025.
    • “Doctors’ groups express concern that non-MD providers practicing without physician oversight may pose risks to patients.
    • “A 2023 study found that allowing nurse practitioners to work without physician supervision reduced deaths that could have been prevented through healthcare by 2%”
  • Fierce Healthcare relates,
    • “Even without counting the multi-billion hit tied to the early termination of a major joint venture and outsourcing arrangement, CommonSpirit Health’s operations took a bruising during the three months ended March 31.
    • “The major Catholic nonprofit system reported Friday a $578 million operating loss (-5.8% operating margin) during the third quarter of its fiscal year. That’s after two key adjustments: normalization for delayed income received through California’s provider fee program; and removing the nearly $2.5 billion of “special charges” the system recorded on paper for the quarter that include contract termination and intangible asset impairment stemming from its breakup with Tenet Healthcare’s revenue cycle services business. 
    • “For comparison, CommonSpirit had logged an $85 million operating loss (-0.9% operating margin) a year prior with the California provider fee program adjustment. Across the first nine months of the fiscal year, the system is looking at a $743 million operating loss (-2.4% operating margin) for 2026 and a $282 million operating loss (-1.0% operating margin) in 2025, with the same adjustments.” 
  • Health Exec tells us,
    • “The days when most doctors worked in independent practice settings are fading from memory like old photoprints in a musty scrapbook.
    • “Taking their place is an era dominated by physician employment. And the employers are not only hospitals but also a “vast array of corporate entities with various financial incentives for employing physicians.”
    • “The quote is from the authors of a new report compiled by Avalere Health for the Physicians Advocacy Institute, also known as PAI.
    • “The shift towards corporatization of physician practice, the PAI analysts add, has “significant implications for costs, patient care and the future practice of medicine.”
    • “The report looks at trends in practice acquisitions as well as physician employment over the eight-year stretch from January 2018 to January 2026.”
  • MedCity News informs us,
    • “Anomaly Insights, an AI-powered payer intelligence company, announcedWednesday that it raised $17 million in funding.
    • “The company’s platform analyzes healthcare transactions to identify payer behavior patterns, policy changes and adjudication deviations. It helps predict at-risk payments so providers can proactively ensure claims are paid accurately. It also detects new denial patterns and identifies revenue opportunities. Currently, Anomaly is being used across more than 20 health systems.
    • “Specifically, the company seeks to solve the issue of “not knowing whether a healthcare encounter will be paid for or not before it happens,” said Mike Desjadon, CEO of Anomaly.”

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Generative AI, Medical / Rx research, Medicare, Mental health care, Obesity, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Roll Call informs us,
    • “Republican leaders in Congress scored some victories this week in nominations and appropriations but struck out on easily advancing their partisan “reconciliation 2.0” proposal to fund immigration enforcement.
    • “The bill faces a hurdle in the form of the Senate Parliamentarian, who on Thursday evening advised that several provisions violate the Senate’s restrictive Byrd rule — and more could be coming. 
    • “This throws an obstacle in the way of the GOP’s efforts to provide some $72 billion in funding for immigration enforcement by President Donald Trump’s June 1 deadline, as Republicans will have to rewrite parts of the package to pass it with the filibuster-proof budget reconciliation process, requiring a simple-majority vote to pass, instead of the 60-vote threshold required for regular legislation.
    • “Republicans are expected to try to rewrite the legislation to remedy the violations or, if that’s not possible, remove the offending provisions ahead of a Homeland Security Committee markup of the title next week. 
    • “Senate Parliamentarian Elizabeth MacDonough was expected to hold a second “Byrd bath” Friday to hear arguments from Democratic and Republican Senate staff about the Judiciary Committee’s portion of the bill, including Secret Service money for security upgrades tied to Trump’s White House ballroom project.” 
  • Mercer Consulting reports,
    • “With the midterm congressional elections approaching and healthcare affordability top of mind for voters, lawmakers are actively considering new healthcare transparency reforms, including requirements for providers to show plainly what patients will have to pay and new billing standards for hospitals.
    • “Senate Health, Education, Labor and Pensions Committee Chairman Bill Cassidy, R-LA, highlighted such price transparency legislation — Patients Deserve Price Tags Act (S 2355/HR 5582) — during a field hearing in Louisiana during last week’s congressional recess. Cassidy’s interest could signal that the legislation, which has may cosponsors from both parties, could soon see action at the Committee. 
    • “The bill would codify and expand current hospital price transparency rules that were established in the first Trump administration by extending requirements to clinical diagnostic laboratories, imaging centers, and ambulatory surgical centers. It would also make the prices that hospitals post clearer by requiring actual dollar-and-cents amounts, not estimates, as well as sharply increase financial penalties for hospitals and insurers that fail to disclose their negotiated rates. In addition, group health plans and insurers would have to give patients upfront, personalized cost estimates through an online self-service tool, as well as paper or phone options, before care is provided. The bill also ensures group health plans have access to claims data and prohibits third-party administrators from restricting that access.
    • “While several plan sponsor trade groups publicly support the legislation, they are working with lawmakers to make certain provisions more workable and better aligned with the PBM-focused transparency rules enacted in the Consolidated Appropriations Act, 2026 and proposed by the Department of Labor.”
  • AHIP lets us know “What They Are Saying: Broad Range of Experts Agree on a Root Cause of Healthcare Cost Crisis.”
    • “The evidence continues to underscore that making healthcare more affordable requires policymakers to address the root causes of high costs head-on through common-sense solutions like cracking down on anti-competitive hospital mergers and implementing site-neutral payment reforms.
    • “To learn more about how rising hospital costs are driving premiums higher and what policymakers can do to address it, visit AHIP.org/CostConnection.”
  • Fierce Healthcare relates,
    • “A bipartisan group of lawmakers in both chambers of Congress has reintroduced a bill aimed at barring companies from owning both a pharmacy benefit manager and retail pharmacies.
    • “The bill, called the Patients Before Monopolies (PBM) Act, would force conglomerates that include a PBM to divest pharmacies that they own. The legislation has existed in some form since 2024, and since its first introduction, Arkansas has implemented a similar legislation at the state level.
    • “Last month, Tennessee legislators also passed a bill that would prevent PBMs from owning pharmacies, which the governor is expected to sign into law.”
  • Mercer adds,
    • “Several developments in 2026 signal that the Trump administration is committed to improving behavioral health benefits for group health plan participants and beneficiaries — but the administration intends to put its own stamp on enforcement of the Mental Health Parity and Addiction Equity Act and propose new rules interpreting the landmark law.”
  • Per an HHS news release,
    • “The Substance Abuse and Mental Health Services Administration (SAMHSA), a division within the U.S. Department of Health and Human Services (HHS), announced today that it has awarded $255 million to Vibrant Emotional Health (Vibrant) to administer the 988 Suicide & Crisis Lifeline. The 988 Lifeline is a national network of more than 200 local crisis contact centers managed by a SAMHSA-funded network administrator. The 988 Lifeline has received more than 25 million contacts via call, text, chat, and ASL videophone since its launch.”
  • Modern Healthcare notes,
    • “The Centers for Medicare and Medicaid Service solicited the healthcare industry on ways it can identify and prevent fraud.
    • “The anti-fraud push drew cautious support, with providers and insurers seeking clear guardrails.
    • “Providers and insurers urged CMS to target high-risk services and avoid sweeping actions that would hamper care.” * * *
    • “New policies should focus on high-risk activities and not burden the ”vast majority of healthcare providers that are honorable in pursuing a mission to provide high-quality healthcare,” wrote the American Health Care Association/National Center for Assisted Living, which represents long-term care providers.
    • “The agency should also be careful not to add administrative burden since hospitals “already operate under extensive oversight requirements,” the American Hospital Association wrote.”
  • Beckers Payer Issues explains the federal crackdown on healthcare fraud, waste and abuse.
  • Newfront brings us up to date on the 2026 PCORI fee, which applies to FEHB and PSHB plan carriers.
    • “IRS Notice 2025-61 adjusts the Patient-Centered Outcomes Research Institute (PCORI) fee to $3.84 per covered individual for health plan years ending on or after October 1, 2025 and before October 1, 2026, including 2025 calendar plan years. This represents a 37-cent increase from last year’s $3.47 PCORI fee.
    • “Action Item: The annual PCORI fee must be reported and paid to the IRS by July 31, 2026, via the second quarter Form 720 (Rev. June 2026).”
  • HR Dive points out,
    • “The U.S. Equal Employment Opportunity Commission plans to end employee demographic data reporting, according to a proposal sent to the White House on Thursday.
    • “The agency wants to get rid of EEO-1, EEO-2, EEO-3, EEO-4 and EEO-5 reporting requirements. EEOC also wants to axe reporting requirements related to Title VII of the Civil Rights Act, the Americans with Disabilities Act, the Genetic Information Nondiscrimination Act and the Pregnant Workers Fairness Act.
    • “EEO-1 reporting has been a cornerstone of HR duties, required by firms with 100 or more employees and federal contractors with 50 or more employees that meet certain requirements. EEOC and analysts have used it to assess demographic data nationally, and — while the process is sometimes viewed as burdensome — employers have reportedly used the collected data for self-assessments regarding nondiscrimination and diversity.”
  • The Census Bureau notes,
    • “Since 2020, city centers of many major U.S. metro areas have had sluggish population gains, with some places even declining. But where growth did occur, it was mostly on the outer edges of these metro areas — with some exceptions.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “With the ink barely dry on outgoing commissioner Marty Makary’s resignation, another top regulator may be heading for the exit at the FDA. 
    • “Tracy Beth Høeg, M.D., Ph.D.—who was named acting director of the agency’s Center for Drug Evaluation and Research (CDER) following the departure of veteran oncologist Richard Pazdur, M.D., last December—is now expected to depart in Makary’s footsteps, Reuters reported Friday, citing three sources familiar with internal plans at the regulator.” * * *
    • “Reuters clarified in its report that the CDER chief’s departure is likely, but that the decision has not yet been finalized.” 
  • and
    • “With the help of DNA testing company Natera and its personalized molecular residual disease (MRD) blood test Signatera, Roche’s PD-L1 inhibitor Tecentriq has chalked up its eleventh U.S. indication in the form of a new bladder cancer approval.
    • “Tecentriq and subcutaneous Tecentriq Hybreza can now be used as an adjuvant treatment for adult patients with muscle-invasive bladder cancer (MIBC) who have circulating tumor DNA molecular residual disease (ctDNA MRD) following a cystectomy, as identified by Signatera.” 
       
  • Biopharma Dive relates,
    • “The Food and Drug Administration has placed a clinical hold on Aardvark Therapeutics’ drug for Prader-Willi Syndrome, escalating a trial stoppage that began when signs of potential heart problems were detected in a study of healthy volunteers. 
    • “Aardvark said Thursday it will “unblind,” or reveal which enrollees in a late-stage trial received ARD-101, in order to help investigators and regulators determine whether the drug is safe and effective enough to continue testing in humans.
    • “The company has dosed 68 people in the placebo-controlled Phase 3 trial and another 19 in an open-label extension study, both which were intended to measure whether ARD-101 can address the “hyperphagia,” or insatiable hunger, distinctive to Prader-Willi. The cardiovascular concerns emerged from a safety trial in healthy people who’d received much higher doses than what was administered in the other studies.” 
  • Cardiovascular Business tells us,
    • “Stryker Sustainability Solutions, an Arizona-based division of Stryker focused on reprocessing single-use medical devices, has recalled certain lots of several reprocessed electrophysiology (EP) catheters. The recall, which covers more than 8,000 devices overall, was initiated after the company identified incomplete seals due to a process control issue.
    • “According to the U.S. Food and Drug Administration (FDA), this is a Class II recall. This means the agency believes the devices “may cause temporary or medically reversible adverse health consequences.”
  • The Wall Street Journal points out,
    • “Twenty people in Japan who took Amgen’s rare-disease drug Tavneos have died, and at least 22 developed a potentially fatal liver injury, according to Kissei Pharmaceutical, which sells the medicine in the country.
    • “Kissei told doctors Friday to stop prescribing the drug to new patients.
    • “The Japanese drugmaker said the 20 deaths occurred in people who had suffered a serious liver “impairment” and attributed 13 of the deaths to a condition, called vanishing bile duct syndrome, marked by the destruction of the ducts that carry bile out of the liver.
    • “Kissei said causal links to Tavneos hadn’t been confirmed in all 20 deaths.” * * *
    • “The medicine went on sale in Japan in 2022, according to Kissei. Also that year, Amgen bought the drug’s developer, ChemoCentryx, for $3.7 billion.
    • “In January, the FDA asked Amgen to voluntarily pull the drug from the U.S. market, but Thousand Oaks, Calif.-based Amgen refused.
    • “Then in March, the FDA said it had identified 76 global cases of serious liver injury linked to Tavneos, including eight deaths. Most were reported in Japan. Of the 76 global cases the FDA identified, seven involved the syndrome, and three of those patients died.
    • “In late April, the FDA moved to formally begin withdrawal proceedings.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of May 15, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity started later than expected in most regions of the United States, though illness is not more severe compared with recent seasons. RSV activity has peaked in many regions of the country. This unusual timing means higher levels of RSV activity may continue into May for some regions.
    • “COVID-19 activity is low in most areas of the country.
    • “Seasonal influenza activity is low.”
  • The University of Minnesota’s CIDRAP reports,
    • “The Centers for Disease Control and Prevention (CDC) today confirmed 51 new measles cases in a nationwide outbreak that has now reached 1,893 infections. All but nine cases are locally acquired, with the rest related to international travel.
    • “The agency reported two new outbreaks, for a total of 27. Last year the nation saw 48 outbreaks and 2,288 cases for the entire year. The United States could top that total in the coming months.
    • “Of this year’s cases, 21% involve children younger than 5 years, and 76% involve kids and young adults up to 19 years. Among all 2026 patients, 92% have been unvaccinated or have an unknown vaccine status. Six percent of patients this year have been hospitalized, compared with 11% last year.”
  • The American Hospital Association News relates,
    • “A Centers for Disease Control and Prevention report released May 14 found that U.S.-reported dengue cases in 2024 increased 359% above the annual average from 2010-2023. Dengue is a mosquito-borne viral disease that can cause mild to severe illness and death. There were 3,798 cases reported to the CDC in 2024, compared to the average of 828 from 2010-2023. The report found that 97.2% of cases in 2024 were travel-associated and that 2.8% were acquired locally. Individuals age 50-59 accounted for 21.8% of cases, and 57.5% of cases occurred in Hispanic or Latino individuals. In addition, 36.1% of patients were hospitalized and a total of six patients died. Most travel-linked cases were acquired in the Caribbean (34.1%), North America (24.3%) and Central America (15.6%).” 
  • Health Day informs us,
    • People who have survived a heart attack appear to have a higher risk of brain decline into dementia, a new study says.
    • On average, heart attack survivors have a yearly 5% increased risk of developing cognitive impairment, researchers reported today in the journal Stroke.
    • “Having had a heart attack in the past may speed up the decline in memory and thinking over time,” said lead researcher Dr. Mohamed Ridha, an assistant professor of neurology at Ohio State University in Columbus.
    • “Given the rising burden of dementia and cognitive decline among Americans, it is important to understand how cardiovascular disease affects their brain health,” Ridha said in a news release. “This knowledge can help heart attack survivors take steps to improve their brain health as they age.”
  • and
    • “Offering sigmoidoscopy screening reduces colorectal cancer (CRC) incidence in men and women — with a greater reduction among men — and reduces CRC mortality in men, according to a study published online May 12 in the Annals of Internal Medicine.
    • “Edoardo Botteri, Ph.D., from the Norwegian Institute of Public Health in Oslo, and colleagues report on the benefits of sigmoidoscopy after 23 years in a randomized controlled trial involving persons aged 50 to 64 years. A total of 100,210 persons were randomly assigned to screening with once-only sigmoidoscopy with or without one fecal immunochemical test or to no screening. The intention-to-screen analyses included 98,654 persons: 20,552 in the screening group and 78,102 in the no-screening group.
    • “The researchers found that the 23-year cumulative risk for CRC was 4.3 and 6.0 percent in the screening and no-screening groups, respectively, among men. The corresponding risks were 4.2 and 4.7 percent among women. In men, the 23-year cumulative risk for CRC death was 1.4 and 2.2 percent in the screening and no-screening groups, respectively, while in women, the corresponding risks were 1.3 and 1.4 percent. The strongest effect was seen for rectosigmoid cancer. Screening benefits were not changed with the addition of fecal blood testing.”
  • Healio adds,
    • “The survival benefit conferred by lung cancer screening in real-world settings may be smaller than observed in the pivotal trial on which national screening guidelines are based, study results suggest.
    • “Veterans receiving primary care in the VA health system exhibited a threefold higher risk for all-cause mortality than participants in the randomized National Lung Screening Trial (NLST) who had similar age and tobacco history.
    • “This is one of the first times we have been able to directly compare people who were enrolled in the trial with people in a real-world cohort who are eligible for screening,” Alison S. Rustagi, MD, PhD, assistant professor in University of California San Francisco’s department of medicine, told Healio. “It is not often that we see hazard ratios on the order of 3 in observational analyses. This shows a profound difference between these two populations.”
  • Per Medscape.
    • “Orforglipron, an oral GLP-1 receptor agonist, helps maintain weight loss after injectable therapies like tirzepatide and semaglutide, offering a practical continuation option for patients. Cardiometabolic benefits are largely preserved despite some weight regain.”
  • Per an National Institutes of Health news release,
    • “A group of pediatric eye disease researchers supported by the National Institutes of Health (NIH) has launched an open-access tool designed to help manage pediatric cases of amblyopia, a condition in which the brain fails to properly develop normal vision in one or both eyes early in life. It is the leading cause of preventable single-eye (monocular) vision loss, affecting three of every 100 children in the nation. The tool is aimed at expanding access to evidence-based amblyopia clinical-decision-making expertise amidst a shortage of pediatric eye care specialists in the United States.
    • “This online tool quickly distills the relevant literature into individualized treatment advice for busy clinicians anywhere with internet access. Those without internet access can utilize the article figures as clinical reference sheets,” said article lead author, Allison Summers, O.D., associate professor, Oregon Health & Science University, Portland.” * * *
    • “Known as the Amblyopia Navigator Decision-Support Instrument (ANDI), the tool is designed to guide any eye doctor through the diagnosis of amblyopia. Once amblyopia is diagnosed, ANDI helps to guide the eye care clinician without specialty training in pediatric eye care through management options. The tool helps the eye doctor determine the best glasses prescription for the patient based on a few clinical findings. The tool also helps the doctor determine how long to monitor whether glasses alone are improving vision, which can work for up to a third of children without any further treatment.
    • “If glasses are not enough, ANDI walks the eye doctor through next steps: patching the stronger eye for a couple of hours a day, using atropine eye drops to temporarily blur the stronger eye, or considering newer digital treatments delivered through specially designed games or videos. If a child stops making progress, the tool advises whether to increase the intensity of treatment, switch approaches, reassess the glasses prescription, or refer to a specialist. It provides steps for follow-up visits and what signs of recurrence to watch for after treatment ends. The tool can be used at an initial visit, or any follow-up visit in their amblyopia care journey.
    • “ANDI was developed by PEDIG, an NIH-funded research network with over 400 investigators, and it draws on evidence from 147 published studies. To access ANDI, go to https://public.jaeb.org/pedig.”

From the U.S. healthcare business and artificial intelligence front,

  • Mercer consulting offers “bold strategies” for payers to better control high cost members.
    • “While stop-loss coverage can help mitigate risk, many employers are finding it’s no longer enough. Unsurprisingly, “more focused management of high-cost claimants” is the top priority of large US health plan sponsors in their strategic planning for the next few years. In this post, we’ll discuss four areas where focused efforts can help employers rein in costs.”
      • Understand your data: Analyzing claims to gain clarity. 
      • Strategic oversight of medical specialty pharmacy and gene/cell therapies. 
      • Take a peekaboo view into neonatal intensive care unit management. 
      • Outlier inpatient stays.
  • Fierce Healthcare reports,
    • “CVS’ Omnicare unit has secured court approval to sell its business to virtual care company GenieRx Holdings, the healthcare giant announced Thursday.
    • “GenieRx, which offers an array of virtual health and medication services, is a joint partnership between Milrose Capital, a private equity firm, and Integro Asset Management, a healthcare-focused investment firm. Per court documents, the deal includes $250 million in cash as well as certain other liabilities, such as payroll expenses.
    • “In the announcement, CVS said that in combining with GenieRx, Omnicare will “have the opportunity to strengthen its service.” It will also continue to support it current clients in the lead up to closure, which is expected later this year, pending needed regulatory approvals.”
  • Beckers Hospital Review discusses “three barriers to GLP-1 adherence — and how systems are overcoming them.
    • Patients discontinue therapy early
    • Care models incompatible with sustained support
    • Costs and side effects deter patients.
  • Fierce Pharma tells us,
    • Total prescriptions for Eli Lilly’s Foundayo reached 10,248 for the week that ended May 8, up from 7,335 the prior week, according to IQVIA data cited by Citi. While still on the rise, Foundayo’s growth pace continued to lag behind that of Novo Nordisk’s Wegovy pill during the same stage of their launch. 
    • Wegovy’s total scripts rose by 1.3% week over week to nearly 446,000, as its share in the obesity GLP-1 market climbed 0.1 percentage point to 40.5%, according to Citi.
    • However, Wegovy’s growth apparently didn’t come from its oral formulation. Wegovy pill scripts landed at about 137,000 for the week, down from roughly 143,000 the prior week, marking the first time that the pill’s scripts have fallen since the oral launch in early January.
    • Scripts from the Wegovy pill made up 31% of total Wegovy scripts for the period, down 2 percentage points from the previous week. Still, Citi analysts argued that this roughly one-third of share “suggests preferences for oral formulations.”
    • Even as Wegovy gained ground, Lilly’s Zepbound remained the obesity market leader, with 59.5% share, as its nearly 656,000 scripts marked 0.8% growth week over week. 
  • Beckers Payer Issues offers payer perspectives on artificial intelligence tools.
    • “Using AI solutions to augment the work done by humans is an attractive solution for many payers.
    • “Getting started with these technologies, however, can feel daunting.
    • “To learn more about what it takes for payers to successfully incorporate AI and support more members, Becker’s Healthcare recently spoke with Chris Caramanico, CEO of Elligint Health, Amy Qureshi, RN, executive vice president of product strategy at Elligint Health, and Steven Tolle, chairman of the board at Elligint Health. Mr Tolle has significant experience developing and implementing AI from his time at IBM, Merge and IgniteData and addition serves as Chief of AI Strategy at Elligint Health.”
  • Fierce Healthcare adds,
    • Nearly 80% of payers now prefer implementing vendor-built artificial intelligence tools rather than developing internal capabilities, a new survey from Innovaccer found.
    • The survey draws insights from 63 health insurer organization leaders, including regional health plans to national carriers, the healthcare technology and AI company said in a press release. Respondents were polled in mid-December 2025 to mid-January, and include senior and C-suite executives.
    • Innovaccer CEO and co-founder Abhinav Shashank told Fierce Healthcare that the shift to outsourced solutions reflects the focus of how to “truly operationalize AI.” 
    • “What we are seeing is an emergence of how do you have platforms that companies can effectively offer that allow for more agentic orchestration,” Shashank said. “Because the reality of it is the technology is going to be a massive addition to how payers operate.” 
  • NBC News relates,
    • “Over the past two years, medical providers across America have quietly embraced a new AI tool called OpenEvidence to help them make clinical decisions, brush up on medical knowledge and even prepare for their licensing exams. The service, a sort of chatbot for doctors, was used by about 65% of U.S. doctors across almost 27 million clinical encounters in April alone, the company told NBC News.
    • “Everyone is using it,” said Dr. Anupam Jena, an internal medicine physician at Massachusetts General Hospital in Boston and a professor of healthcare policy at Harvard. “Its growth really has been exponential.”
    • “NBC News spoke with over two dozen doctors, hospital administrators, medical students and healthcare researchers from Hawaii to Maine to explore the rise of OpenEvidence. Each individual said they either used it regularly themselves or knew someone who did.
    • “Almost two-thirds of physicians — or roughly 650,000 doctors — in the U.S. actively use OpenEvidence, while another 1.2 million use it internationally, OpenEvidence representatives said. With its quick and tailored replies, OpenEvidence has become an AI-era equivalent of consulting a colleague for their expert opinion, though the software can also write patient discharge notes and provide custom study tools for doctors’ medical exams.”

Thursday report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Roll Call reports,
    • “If and when the next government shutdown rolls around, the laundry list of consequences will now include a pay freeze for U.S. senators.
    • “On a voice vote, the Senate passed a resolution from Sen. John Kennedy, R-La., that requires the Senate secretary to withhold compensation for the duration of a shutdown.
    • “The change in Senate rules is set to take effect on the date of the 2026 midterm elections to comply with the 27th Amendment to the Constitution, which prohibits a change in congressional salaries from being enacted until after an intervening election.
    • “The speedy passage, which followed a 99-0 procedural vote Wednesday, underscored a growing frustration among lawmakers with the frequency of partial shutdowns.”
  • The American Hospital Association relates,
    • “The Centers for Medicare & Medicaid Services has released details on downloading its upcoming fiscal year 2025 Program for Evaluating Payment Patterns Electronic Report, or PEPPER, for critical access hospitals. The report, set to release this month, summarizes provider-specific Medicare data statistics for areas often associated with improper Medicare payments due to billing, diagnosis related group coding and/or admission necessity issues. CMS said the report would be available through its PEPPER Portal to authorized officials, access managers and users with the staff end user business function in the CMS Identity and Access Management System. A guide and FAQ on accessing the PEPPER are also available for users.”
  • Tammy Flanagan, writing in Govexec, advises federal and postal employees that “Waiting to retire could be worth thousands of dollars.”
    • “Before you rush out the door, consider how a few more years of service can permanently boost your FERS annuity and Social Security benefits.”
  • Fierce Healthcare informs us,
    • “A new ad campaign takes aim at the “misaligned incentives” in the No Surprises Act arbitration process, arguing they “create a ‘fox guarding the hen house’ dynamic.”
    • “The seven-figure campaign from the Coalition Against Surprise Medical Billing, called “Judge Fox,” features a court battle between a pair of chickens and a pair of foxes. The chickens confer and say that a “reasonable judge” would not allow these foxes to freely set prices for medical bills.
    • “Then the judge also turns out to be a fox, meant to illustrate that private equity firms that own providers that purportedly flood the dispute resolution system may also operate the independent entities meant to mitigate these disputes.
    • “The coalition said in a press release that the campaign comes “amid mounting evidence that some private equity-backed providers and IDR middlemen are relentlessly abusing the IDR process to maximize their own profits at Americans’ expense.”

From the Food and Drug Administration front,

  • Bloomberg Law reports,
    • “A lawyer is leading the FDA for the first time, after President Donald Trump‘s selection Tuesday of Kyle Diamantas to serve as acting commissioner after Marty Makary resigned.
    • “The promotion of Diamantas to acting FDA commissioner also marks the second time in history someone leading the agency’s food oversight has been put in charge, a move that comes as the Trump administration advances a range of food policy changes aligned with the “Make America Healthy Again” movement.”
  • Fierce Pharma relates,
    • “BeOne Medicines has entered the BCL-2 arena, securing an FDA green light for Beqalzi that carves out a unique piece of territory ahead of a potential broader clash with market leader Venclexta.
    • “The FDA has granted an accelerated approval to BeOne’s Beqalzi (sonrotoclax) for the treatment of patients with relapsed or refractory mantle cell lymphoma after at least two prior lines of therapy, including a BTK inhibitor, the company said Wednesday.
    • “The go-ahead makes Beqalzi the first BCL-2 inhibitor specifically approved for MCL in the U.S., as AbbVie and Roche’s first-to-market Venclexta has only been used off-label for this type of blood cancer.”
  • and
    • “Taiho Pharmaceutical nabbed an expanded FDA approval for its Inqovi, which can now be taken alongside AbbVie and Roche’s Venclexa (venetoclax) to treat newly diagnosed acute myeloid leukemia in patients who are 75 and older and ineligible for intensive induction therapy. 
    • “The therapy is the first all-oral combination treatment regimen cleared for this specific patient population and represents an alternative to standard-of-care parenteral hypomethylating agent-based regimens, which require frequent visits to the clinic. With a more convenient offering that can potentially reduce the overall treatment burden associated with receiving the standard-of-care at hospitals or infusion centers, Taiho figures that its approach can make a “meaningful impact for patients and caregivers,” chief medical officer Harold Keer, M.D., Ph.D. pointed out in a company release.” 
  • BioPharma Dive tells us,
    • “An experimental Duchenne muscular dystrophy gene therapy from Regenxbio has met its main objective in a pivotal trial, positioning the company to seek an accelerated regulatory clearance in the U.S.
    • “Three months after treatment with Regenxbio’s therapy, RGX-202, 28 of the 30 study participants receiving muscle biopsies produced at least 10% of normal levels of a diminutive protein, “microdystrophin,” believed to help Duchenne patients. That result hit the trial’s main goal and passed a key threshold needed to support an approval. Nine volunteers with at least one year of follow-up also demonstrated statistically significant improvements, from the study’s start, on multiple tests of motor function.
    • “Regenxbio did report two serious adverse events among treatment recipients — one case of heart inflammation and another of asymptomatic liver injury. Both were “easily managed and resolved within weeks” without further incident, and the average levels of liver inflammation markers in those who got RGX-202 didn’t surpass the “upper limit of normal.” Still, company shares fell by more than 35% as the safety findings “muddy the update,” wrote Leerink Partners’ analyst Mani Foroohar.”

From the judicial front,

  • Per Justice Department news releases,
    • “A federal jury in the Southern District of Florida convicted the founder and owner of HealthSplash yesterday for his role in operating a platform that generated false doctors’ orders and prescriptions to defraud Medicare and other federal health care benefit programs out of more than $1 billion.” * * *
    • “According to court documents and evidence presented at trial, Brett Blackman, 42, of Johnson County, Kansas, and his co-conspirators aggressively targeted hundreds of thousands of Medicare beneficiaries to get them to accept medically unnecessary orthotic braces and other items. They then arranged for purported telemedicine doctors to sign bogus prescription orders for these items, so that their co-conspirators could bill Medicare for them. All told, Blackman and his co-conspirators billed Medicare and other federal health care benefit programs over $1 billion for this unnecessary equipment.
    • “Blackman owned, controlled, and was the CEO of HealthSplash, which acquired Power Mobility Doctor Rx, LLC (DMERx) in September 2017. DMERx was an internet-based platform that generated false and fraudulent doctors’ orders for durable medical equipment (DME) and prescriptions for other items. As part of the scheme, Blackman and his co-conspirators connected pharmacies, DME suppliers, and marketers with telemedicine companies that would accept illegal kickbacks and bribes in exchange for signed doctors’ orders created using the DMERx platform. Blackman and his co-conspirators took a cut for themselves in exchange for the referrals.”
  • and
    • “Takeda Pharmaceuticals, U.S.A. Inc. has agreed to pay $13,670,921 to resolve allegations that it knowingly caused the submission of false claims to Medicare and other federal health care programs by paying kickbacks to healthcare providers to induce prescriptions of Trintellix, an antidepressant medication that Takeda marketed and sold to treat major depressive disorder.”
    • “The Department of Justice is committed to vigorously pursuing violations of the False Claims Act arising from illegal kickbacks,” said Assistant Attorney General Brett A. Shumate of the Justice Department’s Civil Division. “Such conduct can erode the trust that patients place in their healthcare providers and lead to higher drug costs for American taxpayers.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “Health officials in the United States and around the world are assessing and managing potential exposures linked to the hantavirus outbreak on an expedition ship. Some of the American passengers on the ship are quarantining in Nebraska and Georgia. Others returned home earlier.” * * *
    • “David Fitter, the Centers for Disease Control and Prevention official leading the response, told reporters Thursday during a media briefingthat 41 people across the U.S. are under monitoring, but there are no cases.
    • “The people being monitored for symptoms fall into three groups. The first are the 18 passengers who were recently flown back to the United States from the Canary Islands and are being monitored in special facilities in Nebraska and Georgia. The second group comprises passengers who had already left the ship and returned home before the outbreak was identified. 
    • “In the third group are people who may have been exposed during flights with a known and symptomatic patient. That patient was the wife of the Dutch man, the first known patient to became sick, who died April 11 on board the ship. She left the ship and flew to Johannesburg, where she died on April 26.”
  • Per a National Institutes of Health news release,
    • “A scientific team funded by the National Institutes of Health (NIH) has isolated and mapped in detail the first comprehensive group of human antibodies targeting the measles virus. The findings reveal previously unknown details about how the human immune system fights measles and identify specific antibodies capable of reducing the virus to undetectable levels in an animal model. The research could serve as the foundation for development of a measles treatment.
    • “Measles cases have recently increased in the United States and worldwide. More than 470,000 measles cases were reported globally in 2024, and at least 72 outbreaks have been recorded in the United States since January 2025. While effective prevention in the form of vaccination is available, no safe and effective therapies have received regulatory approval in the United States. This leaves people who cannot safely receive the vaccine – the immunocompromised, pregnant women, and infants too young to be vaccinated – with a lack of medical options.
    • “With measles cases increasing, we urgently need effective therapeutics to protect the most vulnerable,” said Jeffrey K. Taubenberger, M.D., Ph.D., acting director of NIH’s National Institute of Allergy and Infectious Diseases. “This research gives us a clear picture for the first time of the most promising targets for antibody-based medicines that could protect or treat people for whom measles vaccination is not an option.”
  • Medscape tells us,
    • “Two new studies have identified risk factors that may be associated with the increasing incidence of colorectal cancer (CRC) among younger Americans.
    • “The majority of cases are sporadic, suggesting modifiable, nongenetic factors may play an important role,” said Mohamed Eldesouki, MD, internal medicine resident at New York Medical College at Saint Michael’s Medical Center in Newark, New Jersey, at Digestive Disease Week (DDW) 2026.
    • “In the first study, Eldesouki and colleagues identified a distinct phenotype, based on multiple factors, associated with an elevated risk in people aged 18-49 years. In addition, they found that inflammatory bowel disease, family history of CRC, severe obesity, and obesity were independent predictors that increased the risk for early-onset vs late-onset CRC more than twofold.
    • In the second study, a history of oral antibiotic exposure was associated with an increased risk for colorectal adenomas, especially among people with a greater or longer history of using these agents.”
  • Med Page Today informs us,
    • “Dementia with Lewy bodies — a disease characterized by faster progression and greater functional decline than Alzheimer’s disease — was confirmed as a predominantly late-onset dementia with incidence rising sharply with age, a systematic review and meta-analysis showed.
    • “Across 12 population-based studies, the pooled incidence was 46.85 per 100,000 person-years (95% CI 23.78-92.30) for people ages 65 and older, and the pooled prevalence was 352.26 per 100,000 population (95% CI 112.25-1,099.79), reported Daniele Urso, MD, MPH, of the University of Bari Aldo Moro in Italy, and co-authors in JAMANeurologyopens in a new tab or window.
    • “In people younger than 65, the pooled incidence was 0.34 per 100,000 person-years (95% CI 0.14-0.83) and the prevalence was 2.52 per 100,000 population (95% CI 1.43-4.44).”
  • Health Day points out,
    • “Women entering menopause are twice as likely to have lower heart health scores than those still having regular periods, a new study says.
    • “Perimenopausal women are more likely to have high cholesterol and blood sugar levels, researchers reported today in the Journal of the American Heart Association.
    • “These problems likely are fueled by varying estrogen levels, which can negatively affect cholesterol, insulin resistance, blood pressure and weight, researchers said.
    • “But diet also plays a powerful role, with women’s healthy nutrition scores declining as they begin and then enter menopause, the study found.
    • “Mid-life women should think of the perimenopausal period as a ‘window of opportunity.’ They should be proactive and not wait until they reach menopause to start checking their blood pressure, cholesterol and blood sugar levels,” said senior researcher Dr. Garima Arora, an professor of medicine at the University of Alabama at Birmingham.”
  • and
    • “Abdominal obesity (AO) is associated with a higher prevalence and greater severity of menopausal symptoms, according to a study published online May 5 in Menopause.” * * *
    • “Educating women early about healthy lifestyle interventions to prevent midlife weight gain is key to improving mental and physical well-being during a tumultuous time frame,” Monica Christmas, M.D., associate medical director for The Menopause Society, said in a statement.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Companies such as UnitedHealth Group, CVS Health, Cigna and Centene recorded strong first quarters.
    • “Earnings reports suggest chronically high medical costs may be subsiding.
    • “Insurers outperformed Wall Street expectations and upgraded earnings guidances, driving share prices higher.
    • “Seasonal factors, a shift toward higher-deductible plans and incomplete claims data cloud insights into cost trends.”
  • and
    • “UnitedHealth Group division Optum Rx has rolled out a new pharmacy benefit manager model the company describes as transparent.
    • “Optum Rx, first in PBM market share, will phase out practices tying revenue to drug prices and shift toward fees.
    • “The company is attempting to respond to criticisms from its customers, the public and policymakers about how PBMs operate.
    • “Chief rivals CVS Caremark and Express Scripts previously announced similar changes.”
    • * * * “The fact that we’re having this discussion shows progress,” said Robert Andrews, CEO of the Health Transformation Alliance, a coalition of large employers that lobbies Congress.”
  • The Wall Street Journal relates,
    • “Much of the public debate over cancer blood tests has focused on early detection products like the Galleri test from a company called Grail, which promises to screen healthy people for more than 50 types of cancer. 
    • “While these tests capture headlines and Super Bowl ads, the more proven opportunity for investors has been in a less glamorous market: checking for cancer recurrence.
    • For a patient who has just had a tumor surgically removed, the critical question is whether every cancer cell is gone. Many oncologists now use blood tests to answer that question months before a traditional scan could. 
    • “Natera NTRA, based in Austin, Texas, holds a near-monopoly in this market, known as minimal residual disease (MRD) testing. Its stock has roughly quadrupled over three years. The company is now valued at about $31 billion, making it the dominant player in what may be a new era of blood-based cancer testing. It has even surpassed Illumina, the sequencing giant on whose technology much of the industry depends. Revenue has grown from roughly $1 billion in 2023 to $2.3 billion last year and is projected by analysts on FactSet to reach $2.77 billion this year.”
  • and
    • “Merck KGaA lifted its full-year sales and earnings guidance, causing its shares to rise 8.2% in European midday trading.
    • “The company now forecasts net sales of 20.4 billion to 21.4 billion euros and organic sales growth of up to 3%.
    • “Merck cited strong momentum in its life-sciences unit and greater resilience in its healthcare division for the improved outlook.”
  • and
    • “State laws restricting private-equity involvement in the medical sector have taken their first scalps, as authorities signal an aggressive approach to enforcement.
    • “Last year, lawmakers in California and Oregon passed measures to prevent corporate healthcare investors from encroaching on medical care, part of a broad backlash against private equity’s role in the sector.
    • “The new laws started to bite last week. In California, Attorney General Rob Bonta unveiled the first settlement for violating the new law, penalizing Aspen Dental Management, which is backed by asset managers Leonard Green & Partners and Ares Management.
    • “Just a day earlier, Oregon hospital operator PeaceHealth scrapped plans to bring in an out-of-state medical-staffing company after a federal judge said the move looked like an end-run around the state’s strictest-in-the-nation ban on corporate medicine.”
  • Beckers Hospital Review tells us,
    • “Becker’s has compiled a list of the hospitals with a CMS 5-star rating for cleanliness.
    • “CMS’ Patient survey (HCAHPS)-Hospital database listed hospital ratings based on the Hospital Consumer Assessment of Healthcare Providers and Systems surveys. This is a national, standardized survey of hospital patients about their experience during a recent inpatient hospital stay. The surveys were completed between July 1, 2024, and June 30, 2025. The data was updated May 13. 
    • “In 2025, 374 hospitals had a five-star cleanliness rating and Wisconsin had the most highly rated hospitals for cleanliness at 30.
    • “This year, 22 more hospitals made it to 5-star ratings, and Texas had the hospitals recognized for cleanliness with 36.”
    • The article includes the list.
  • and
    • Americans are unlikely to see generic versions of semaglutide — the active ingredient in Novo Nordisk’s Ozempic and Wegovy — until at least the end of 2031, according to a May 13 NBC News report.
    • Novo Nordisk first applied for a U.S. patent on semaglutide in 2006. While standard drug patents last 20 years, patent extensions and secondary patents have delayed generic competition in the U.S., experts told NBC News.
  • and
    • “Lentocilin, a penicillin G benzathine product, is back in stock and available to hospitals, clinics and pharmacies nationwide on Cost Plus Drugs’ marketplace.
    • “The restock comes as healthcare organizations continue managing supply disruptions affecting penicillin G benzathine products across the market, according to a May 11 company news release.
    • “Penicillin G benzathine is the only recommended treatment for syphilis during pregnancy and for preventing congenital syphilis — a condition whose national diagnosis rate has risen 203% over five years, according to an alert from the New Mexico Department of Health. The branded equivalent, Bicillin L-A, has been in shortage since 2023 and was further disrupted by a Pfizer recall in July 2025 due to particulates in prefilled syringes.” 
  • MedTech Dive points out,
    • “Johnson & Johnson has launched a new iteration of its Shockwave coronary intravascular lithotripsy catheter that is designed to make it easier for physicians to treat complex calcified lesions and restore blood flow in the arteries.
    • “Called Shockwave C2 Aero, the improvements in the fifth-generation platform are intended to allow clinicians to use the catheter in a broader range of cases. 
    • “The device is available in the U.S. and Japan and will be introduced in Europe and Canada in the coming months, J&J said Tuesday.”
  • Beckers Payer Issues discusses “How AI is turning UnitedHealth, CVS and Elevance into software companies.”

Monday report

David Ermer–CDC, CMS, Electronic health records, FDA, Federal employment benefits, Medicare, No Surprises Act, OPM, Patient safety, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Per an HHS news release,
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. visited Ohio this week as part of his “Take Back Your Health” tour. He met with the CEOs of the Cleveland Clinic, University Hospitals, and MetroHealth—three of the nation’s leading health systems—following a tour of the Cleveland Clinic. He also visited a Head Start program, a regenerative farm, and an addiction recovery facility, spoke at the City Club of Cleveland, and spent an afternoon at Summa Health. The tour highlighted the Secretary’s commitment to a prevention-first approach to healthcare as the pathway to Make America Healthy Again.
    • “Across Ohio, I saw communities move beyond symptom management and confront the root causes of disease head-on,” said Secretary Kennedy. “From visiting local programs to meeting with the CEOs of the Cleveland Clinic, University Hospitals, MetroHealth, and Summa Health, we are aligning leaders at every level around a prevention-first approach to reverse the chronic disease epidemic and deliver on President Trump’s mandate to Make America Healthy Again.”

  • FedSmith points out,
    • “In late 2025, the Centers for Medicare & Medicaid Services (CMS) released its proposed rule for Contract Year 2027, outlining significant changes to Medicare Advantage (Part C) and the Medicare prescription drug program (Part D).
    • “While many federal retirees rely on FEHB coverage, Medicare decisions—especially around Part B and Part D—remain one of the most important and misunderstood planning areas. This proposed rule signals where Medicare is heading next—and what federal retirees should be watching now.”
    • The article explains these changes.
  • Federal News Network reports,
    • “Despite some hiring occurring across agencies, overall employment in the federal government is continuing to decline. That’s according to the latest jobs report from the Bureau of Labor Statistics. BLS reported that in April, federal employment numbers decreased by another 9,000 jobs. Since peaking in October 2024, the federal sector’s numbers are now down by 11.5%, or 348,000 jobs.” 
  • STAT News relates,
    • “Two years ago, my old pal Rachel Cohrs Zhang and I reported how Medicare’s actuaries predicted the new Alzheimer’s drug Leqembi would cost the program $3.5 billion in 2025. It turns out that prediction was way off.
    • “Through the first three quarters of 2025, Medicare spent $139 million on Leqembi (made by Eisai and Biogen) and $74 million on Kisunla (a newer one made by Eli Lilly), federal data show. Together, that equals $213 million across 19,000 patients, and would be around $280 million for the entire year — a small fraction of the original estimate. Uptake for the drugs has been so muted that Medicare is not forecasting significant spending on them in 2026 or 2027.
    • “Predicting the myriad health care needs for a pool of 70 million older adults and people with disabilities is not an easy task. But neurologists and policy experts told me the lower-than-expected spending lines up with the challenges that have faced the Alzheimer’s drugs since their approvals: The intravenous medications are not easy to administer and require a lot of imaging; the population of patients who are eligible is limited; and the drugs continue to have little meaningful benefits while carrying a risk of severe side effects like brain bleeding.
    • Read Bob Hermans’ new story to learn more
  • and
    • “Changes to the no surprise billing law’s controversial arbitration process could come at any moment. Doctors and other providers are getting a lot more face time with the federal officials writing the regulations, my colleague Tara Bannow reports in a new story.
    • “Health insurers say providers are abusing the system by ramming through high volumes of ineligible cases. Providers claim insurers are not paying up when they lose and don’t give enough information. Ultimately, providers are winning more than 80% of cases, getting arbitration awards that are three to nine times the in-network rates. 
    • Read Tara’s story to find out the lobbying pitches from R1, Radiology Partners, the Blues, and employer groups.”

From the Food and Drug Administration front,

  • Beckers Hospital Review tells us,
    • “The fate of FDA Commissioner Marty Makary, MD, remained unclear May 11 after multiple news outlets reported May 8 that President Donald Trump had signed off on a plan to oust him — reports the president publicly waved off the same day.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced it is soliciting input on efforts with respect to drug repurposing to help address unmet medical needs across a range of diseases and conditions. 
    • “Identifying potential new uses—such as a new indication or a new population—for FDA-approved drugs can help accelerate the availability of treatments by using existing knowledge about the drugs, including a drug’s safety profile. This request for public input is part of a broader FDA initiative to update the labeling of FDA-approved drugs, when supported by sufficient evidence, to ensure that information in the labeling is clinically meaningful for health care providers and patients and scientifically up to date.”
  • MedPage Today informs us,
    • “The FDA on Friday [May 8] issued guidance for manufacturers collecting postmarketing data on the safety of approved drugs and biologics in pregnancy, with the goal of better understanding potential risks for the pregnant patient and fetus.
    • “Currently many medical products may be recommended to pregnant women by healthcare providers in spite of the fact that data from the clinical trials used for FDA approval were insufficient to assess safety during pregnancy,” Tracy Beth Hoeg, MD, PhD, the agency’s top drug regulator, said in a press release “This guidance provides specific recommendations about how postmarketing data can be leveraged and studies can be designed so clinicians and the public can be better informed about product safety and pregnancy-related risks can be more promptly identified.”
  • NBC News reports,
    • “The Food and Drug Administration removed the black box warning from hormone replacement therapies late last year, and recently, the most insured type, the estrogen patch, has been in short supply amid a boom in the therapy’s popularity.
    • “it’s unclear when supplies will rebound. Meanwhile, there are other options for hormone replacement therapy.”
  • Fierce Pharma lets us know,
    • “Argenx is poised to expand the reach of its generalized myasthenia gravis (gMG) treatment Vyvgart and subcutaneous Vyvgart Hytrulo with an expanded FDA nod that covers a wider pool of disease serotypes. 
    • “The label expansion now covers “all serotypes of adult patients living with gMG,” including anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive and triple seronegative gMG, argenx said. In the company’s phase 3 Adapt Seron study, the overall population of Vyvgart-treated patients experienced “rapid, significant and sustained improvements” in symptoms including speech, vision, physical function and other disease measures.” 
  • and
    • Roche’s intravenous-infused relapsing-remitting multiple sclerosis (RRMS) treatment Ocrevus scored a pediatric indication from the FDA, clearing the therapy for patients 10 and older and introducing a new treatment option to the underserved population. 
    • The agency based its approval on a clinical trial comparing Ocrevus to Novartis’ Gilenya (fingolimod), which was until now the only FDA-approved pediatric RRMS treatment. In the study, Ocrevus proved noninferiority to Gilenya in reducing patients’ annualized relapse rate and superiority in reducing new or enlarging T2 lesions and gadolinium-enhancing T2 lesions. 

From the public health and medical / Rx research front,

  • The Wall Street Journal shares what the Journal “knows about hantavirus drugs and vaccines in development.”
  • The New York Times reports,
    • “For about a decade, scientists have had remarkable success curing some blood cancers by modifying a patient’s own immune cells to recognize and kill the malignant cells.
    • “That same approach may help control H.I.V., among the wiliest of viruses, scientists will report on Tuesday. After a single infusion of immune cells engineered to recognize the virus, two people in a new study have suppressed their H.I.V. to undetectable levels, one of them for nearly two years.
    • “The data is scheduled to be presented at a gene therapy conferencein Boston, but the researchers shared an early copy with The New York Times.
    • “The treatment is years, if not decades, from being widely available, but the study offers what scientists call “proof of concept,” and the tantalizing hope that a single shot could one day offer lifelong relief from H.I.V.
    • “It is inspiration and a potential road map to get to where we need to go,” said Dr. Steve Deeks, an H.I.V. expert at the University of California, San Francisco, who led the trial.
    • “Other scientists were enthusiastic about the milestone.”
  • Radiology Business relates,
    • “Vigilance is needed to ensure patient safety in pediatric MR imaging, experts warn in new research published Friday by JACR. 
    • “Safety events remain relatively common in pediatric imaging, though most do not result in significant patient harm. However, these occurrences have the potential for serious consequences for patients, their parents or guardians, and MRI staff. 
    • ‘The conclusions are based on an analysis of safety data from five leading pediatric hospitals, spanning 2017 to 2022. Over the course of five years, there were about 146 pediatric MRI safety incidents that occurred, out of nearly 541,000 scans conducted. 
    • “Although uncommon, MRI safety incidents do occur in Zone IV of pediatric imaging departments,” corresponding author Jonathan R. Dillman MD, MSc, with the Department of Radiology at Cincinnati Children’s Hospital, and colleagues concluded. “While most cause no serious harm, their persistence and potential for catastrophic outcomes highlight the need for continued vigilance and ongoing safety improvements.”
    • “Zone 4 refers to the MRI scanner room, which presents the greatest risk of harm for both patients and staffers.” 
  • Med City News considers “Why We’re Still Finding Cancer Too Late>’
    • “The truth is there are ways to understand our cancer risk more precisely than we do today, and there are tools to manage it. What’s missing is awareness, access, and a system built to help us use these tools before something goes wrong.” * * *
    • “Healthcare innovators are shifting how we define and assess cancer risk, but education on evidence-based screening and risk-reduction practices needs to be front and center alongside these efforts so fewer people will ever have to say, “I wish I knew earlier.” Just like treatment options, prevention is not “one size fits all,” but a highly personalized approach. Individuals today can understand their risk of cancer far more clearly than any prior generation and, with the right information, resources, and support, can take powerful steps to reduce it. It won’t happen automatically. Our system is built to react to disease rather than anticipate it, which means personalized prevention rarely starts unless providers and patients help initiate it. 
    • “Instead of waiting for a cancer diagnosis, it’s time to ask the question: “What is this patient’s personal risk of cancer, and what can we do, starting now, to lower it and increase their chances of catching it early?”
  • A National Institutes of Health press release adds,
    • “Findings from a study supported in part by the National Institutes of Health (NIH) have identified a new model for predicting outcomes for hypertrophic cardiomyopathy (HCM), a heart condition with a prevalence of 1 in 500 people and a frequent cause of sudden cardiac death. Specifically, the findings demonstrate that incorporating prospective data including clinical history, imaging, and blood biomarker data into risk assessment can improve prediction of adverse cardiac events in people with HCM.
    • “The large, international study, called the Hypertrophic Cardiomyopathy Registry, was initially funded by NIH’s National Heart, Lung, and Blood Institute (NHLBI). The findings were published in JAMA.
    • “Current risk prediction guidelines for hypertrophic cardiomyopathy are imperfect, as they predict only sudden cardiac death, and not heart failure or other fatal and nonfatal cardiac adverse events,” said Christopher Kramer, M.D., a principal investigator of the study and cardiologist at the Heart and Vascular Center of the University of Virginia Health System. “This study is a major advance in that it provides evidence that incorporating these additional assessment methods better predicts risk of adverse outcomes.”
  • Health Day tells us,
    • “People hospitalized for opioid overdose have a higher rate of subsequent OD than previously thought, a new study says.
    • “Previously, it was estimated that about 6% of people who survived an opioid overdose wound up with a repeat overdose during the following year.
    • “But new results indicate that 21% experience a repeat OD after an emergency department visit for opioid overdose, researchers reported May 7 in the Journal of the American Medical Association.
    • “Patients’ risk of death also increased alongside their number of additional overdoses, the study found.
    • “Increased use of powerful synthetic opioids like fentanyl are fueling the rising risk of repeat overdose, researchers said.”
  • and
    • “Exposure therapy can successfully protect preschool children from peanut allergies, a new study says.
    • “Children ages 1 to 3 fed small amounts of peanut daily slowly became accustomed to them, researchers reported May 6 in The Lancet Regional Health Europe.
    • “All children who followed the protocol achieved the goal of eating three and a half peanuts without experiencing an allergic reaction, and most were able to consume up to 25 peanuts,” researcher Caroline Nilsson said in a news release. Nilsson is an associate professor of clinical science and education at the Karolinska Institute in Sweden.
    • “We consider the treatment to be safe if it is carried out under controlled conditions in a healthcare setting,” she said.”
  • MedPage Today points out,
    • “Human papillomavirus (HPV) vaccination rates varied substantially across and within U.S. regions, according to estimates in a retrospective, cross-sectional analysis, suggesting targeted interventions should focus on the needs of individual states.
    • “Comparing adolescents ages 13-17 years across the country against Alabama — where the 21% without at least one dose of the HPV vaccine approximates the national goal — several Northeast states did significantly better, including Rhode Island (adjusted OR 3.05, 95% CI 1.40-6.66), Massachusetts (aOR 2.19, 95% CI 1.24-3.88), and New Hampshire (aOR 1.72, 95% CI 1.03-2.88).
    • “Several Southern states significantly lagged Alabama in likelihood of HPV vaccination, including Mississippi (aOR 0.41, 95% CI 0.26-0.65), Georgia (aOR 0.45, 95% CI 0.27-0.76), Oklahoma (aOR 0.46, 95% CI 0.30-0.72), Kentucky (aOR 0.55, 95% CI 0.35-0.87), and West Virginia (aOR 0.56, 95% CI 0.36-0.87), reported Chinenye Lynette Ejezie, PhD, of Towson University in Maryland, and colleagues in a JAMA Pediatricsopens in a new tab or window research letter.”
  • Genetic Engineering and Biotechnology News informs us,
    • “For decades, physicians and scientists have thought that metformin, a biguanide drug that is prescribed for millions of people worldwide for type 2 diabetes (T2D), mainly targets the liver to suppress glucose production. A Northwestern University-led study in mice has now found that this “wonder drug” instead acts primarily on the gut, and prevents glucose levels from rising in the blood by driving glucose utilization inside cells lining the intestine.
    • “The research found that metformin slows mitochondrial energy production in gut cells by inhibiting mitochondrial complex I in the intestinal epithelium. This then “co-opts” the intestines to function as a glucose sink, forcing the intestine to metabolize extra sugar. The study also found that another biguanide drug, phenformin, and the structurally unrelated supplement berberine, which is known as “nature’s Ozempic,” appear to engage the same pathway in the gut as does metformin.
    • “The preclinical findings could help to explain several gut-related clinical effects in people who take metformin and suggest that modulating mitochondrial metabolism in the gut may represent an effective strategy for controlling blood sugar. “Metformin essentially helps the intestine suck the glucose out of the bloodstream, which further highlights that the gut plays a major role in regulating blood sugar levels,” said corresponding author Navdeep Chandel, PhD, professor of biochemistry and molecular genetics at Northwestern University Feinberg School of Medicine.”

From the U.S. healthcare business and artificial intelligence front,

  • Fierce Healthcare reports,
    • “Kaiser Permanente’s first-quarter operating performance took a step back in 2026 compared to the year prior, though investments and other sources of income picked up the slack to push the large integrated nonprofit’s bottom line past $2 billion. 
    • “The system reported operating income of $711 million for the quarter, or a 2.1% operating margin, in a Friday evening press release. It had logged $932 million in operating income, or a 2.9% operating margin, in the first three months of 2025.
    • “The organization’s performance came on the back of $34.6 billion in consolidated operating revenue, a roughly 8.7% year-over-year increase, and $33.9 billion of operating expenses, a 9.6% year-over-year increase.
    • “Though it grew in scale, Kaiser noted that it and its subsidiary Risant Health “continue to manage elevated costs in care delivery while taking steps to improve efficiency and maintain affordability.” 
  • and
    • “Omada Health reported revenue of $78 million in the first quarter, up 42% year over year as the company continues to expand its commercial reach and is seeing traction from its big investments in GLP-1 capabilities.
    • ‘The virtual chronic care provider reported strong adoption of its GLP-1 Care Track program while the company also continues to successfully sell multiple chronic condition programs to its existing customer base of employers and health plans, executives said during the company’s Q1 earnings call on Thursday.
    • “Q1 was the strongest first quarter in Omada’s history; on members, on revenue, on gross margin and on adjusted EBITDA,” Steven Cook, Omada Health’s chief financial officer, said during the earnings call. “Over the past year, we have been building capabilities to position Omada for durable growth, prescribing infrastructure, AI-empowered care delivery and an expanding set of GLP-1 and cardiometabolic solutions.”
  • Modern Healthcare relates,
    • “UnitedHealth Group Inc. said it will move away from having profits in its pharmacy benefits unit linked to the list prices of medications, the latest shift to address longstanding criticisms of its business model.
    • “Optum is UnitedHealth’s services arm. UnitedHealth’s Optum Rx unit helps determine which drugs are covered by health insurance plans, including UnitedHealthcare’s and others, and what prices patients must pay to access them. The company handled about 1.7 billion prescriptions last year.
    • “Optum Rx plans to shift to what a top executive called a more transparent fee structure that gives clients clarity into the money it gets from drugmakers. The way those details have been determined has been shrouded in secrecy, leading to claims that Optum Rx benefits from higher drug prices. The new approach is designed to refute those criticisms.” * * *
    • “We want our earnings based on service to the client,” Optum Chief Executive Officer Patrick Conway said in an interview. “We do not want any of those earnings tied to the list price of drugs, period.”
    • “The shift is expected to be complete by the end of next year, Conway said. It’s part of a series of changes the company is making to transform a business model that’s faced criticism from regulators, employers and lawmakers.”
  • The Wall Street Journal tells us,
    • “AstraZeneca is inching closer to its goal of reporting $80 billion in revenue by 2030 as the U.K. drugmaker pushes further into the U.S. and develops new oncology, rare disease and weight-loss drugs.
    • “The pharmaceutical giant has made progress on a pipeline of more than 25 medicines, each expected to generate more than $1 billion in revenue by the close of the decade, Chief Financial Officer Aradhana Sarin said. AstraZeneca hopes those drugs, along with new U.S. manufacturing investments and a direct listing of its shares in New York, will fuel growth.
    • “Revenue has been on the upswing since the company set its $80 billion target in 2024, with 2025 coming in at $58.74 billion. That was up from $45.81 billion in 2023, the year before it set the 2030 target.”
  • Beckers Health IT informs us,
    • “Whoop is rolling out new features to include virtual clinician visits and EHR integration.
    • The Boston-based fitness wearable company announced the updates May 8, positioning the new offerings as part of its broader shift from fitness and performance tracking toward clinical-grade health support, according to a Whoop news release.
    • “The new offerings include live, on-demand video consultations with licensed clinicians, which are expected to launch in the U.S. this summer. Whoop said the feature will allow members to connect with clinicians directly through the app, using months of biometric data, and when available, bloodwork and medical history, to provide a more comprehensive understanding of a member’s health.
    • “Whoop also announced plans to support electronic health record syncing through a partnership with HealthEx. The integration will allow members to access clinical information, including diagnoses, medications and procedures, directly within the app.”
  • Healthcare Dive notes,
    • “An influential group that advises Congress on Medicaid is recommending increasing transparency into artificial intelligence-backed prior authorization and boosting human oversight over automated pre-approvals for care. 
    • “The recommendations come as states and the federal government say they have limited insight into payers’ use of the technology in the safety-net insurance program, which can make it challenging for regulators to monitor for data bias or inaccuracies, analysts said during the meeting.”
  • Tech Target adds,
    • “The Workgroup for Electronic Data Interchange launched a free directory for organizations seeking testing partners for the CMS Advancing Interoperability and Improving Prior Authorization Final Rule (CMS-0057-F), in advance of the Jan. 1, 2027, compliance deadline. WEDI encouraged all organizations impacted by the rule to post their information on the directory and use it to test APIs with eligible partners.
    • “CMS-0057-F requires entities to implement certain HL7 FHIR APIs: Prior Authorization, Payer-to-Payer, Patient Access and Provider Access. The Prior Authorization API can identify documentation requirements for prior authorization approval, while the Payer-to-Payer API enables the exchange of claims and encounter data. The Patient Access API allows patients to access their health information, and the Provider Access API allows payers to share patient data with in-network providers.” * * *
    • “Organizations that want to test can complete a questionnaire that includes contact information, specific APIs available for testing and a link to their website. Organizations can also look for testing partners using the directory and contact the organizations they want to test with. The directory will display summaries of completed testing.
    • “At the time of publication, six entities had posted their information on the directory: Wellmark, Mayo Clinic, Veradigm, Blue Cross Blue Shield of Michigan, NextGen Healthcare and ZeOmega.”


Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, Obesity, OPM, Patient safety, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Federal News Network reports
    • “Nearly 12,000 new retirement claims entered the Office of Personnel Management’s systems last month. Coupled with OPM’s processing of about 17,000 retirement applications, the agency managed to reduce its inventory by several thousand claims. April was the first time OPM’s retirement backlog has dipped below 50,000 claims in more than five months. Currently, digital retirement claims are also being processed in about two-thirds the time of traditional paper applications.”
  • and
    • “Democrats are urging the Office of Personnel Management not to shut down the Combined Federal Campaign. In a letter to OPM this week, lawmakers warned that ending the CFC would be “disastrous” for hospitals, food banks and other organizations that receive charitable donations through the program. OPM recently decommissioned the CFC’s online donation portal, but the agency has not yet confirmed whether the program will be officially dismantled this year. CFC has been in operation since the Reagan administration, a program that lets federal employees contribute to charities around the world.”
  • The Wall Street Journal relates,
    • “The CDC is coordinating with the WHO on a hantavirus outbreak aboard the MV Hondius, despite the U.S. withdrawal from the WHO and CDC cuts.
    • “The U.S. formally withdrew from the WHO earlier this year, following President Trump’s executive order and criticism of its Covid-19 handling.
    • “The Trump administration reduced funding for CDC global health programs, shifting to a fee-for-service model for technical assistance.”
  • KFF Health offers more details on CMS’s Bridge program which will give eligible Medicare beneficiaries access to GLP-1 drugs for weight loss. The Bridge program runs from July 1. 2026, through December 31, 2027.

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “President Trump has signed off on a plan to fire Food and Drug Administration Commissioner Marty Makary, according to people familiar with the matter, following a tumultuous period for the regulator that included clashes over vaping, abortion and drug policy.
    • ‘Makary, a former Johns Hopkins surgeon who became a frequent Make America Healthy Again surrogate on television news programs, is seen by other top administration leaders as struggling to manage his agency, sparring frequently with health department officials and at times with the White House. His tenure has also been dogged by the aftereffects of layoffs led by the Department of Government Efficiency and rapid turnover in the FDA’s leadership ranks. 
    • ‘He would become the latest top lieutenant fired under Health and Human Services Secretary Robert F. Kennedy Jr. since the ouster last summer of Centers for Disease Control and Prevention Director Susan Monarez and the February removal of HHS Deputy Secretary Jim O’Neill.
    • “Trump’s plan isn’t yet final and could change.”
  • The American Hospital Association News relates,
    • “The Food and Drug Administration has issued a Class I recall correction for certain Boston Scientific ACCOLADE pacemakers and cardiac resynchronization therapy pacemakers after identifying a software-related battery issue that could cause affected devices to enter Safety Mode and limit pacing functionality. The correction does not involve removing devices but requires clinicians to upgrade the pacemakers’ software to reduce the risk of premature battery depletion and early device replacement. According to the FDA, continued use of affected devices without the update could result in serious injury or death. Hospitals and clinicians are advised to review affected model and serial numbers, apply the software update during in office visits, monitor patients per manufacturer guidance and report adverse events through the FDA’s MedWatch program.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today issued an approval for Bizengri (zenocutuzumab-zbco), a drug that treats NRG1 fusion-positive cholangiocarcinoma, an ultra-rare, aggressive cancer that forms in the bile ducts. 
    • “Bizengri is the first drug approved for adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.
    • “This approval marks the seventh approval under the Commissioner’s National Priority Voucher (CNPV) pilot program.”
  • Fierce Pharma tells us,
    • “While Eisai and Biogen have already secured an FDA nod for a subcutaneous maintenance dose of their early Alzheimer’s disease drug Leqembi (lecanemab), the partners will have to wait a few months more for the regulator to weigh in on their proposed autoinjector initiation dose. 
    • “On Friday, the companies announced that the FDA has extended the review period for their application to advance their Leqembi Iqlik autoinjector as a starting dose for early Alzheimer’s patients. The three-month delay puts the FDA’s new target action date at Aug. 24, Biogen and Eisai said in a release.”
  • Beckers Hospital Review identifies seven prescription drugs now in shortage.
    • “Active drug shortages in the U.S. rose for the second consecutive quarter in 2026, reaching 223 in the first quarter, according to a recent report from the American Society of Health-System Pharmacists. Meanwhile, the FDA’s own database — which uses a narrower classification — lists 76 drugs currently in shortage, as of May 6.
    • “The database is updated daily to reflect manufacturing recoveries, regulatory actions and how shortages are classified — not solely day-to-day availability at the hospital level.”
  • Here’s a link to “Brown & Brown’s May 6, 2026, PharmaLogic® Spotlight [which] reviews evolving pharmacy dynamics and trends driving prescription drug use and cost to guide benefits decision-making.”
    • “Inside this PharmaLogic® Spotlight
      • “New Drug Approvals Influencing Benefits
      • “GLP-1 Developments
      • “Drug Importation/International Sourcing
      • “Generic and Biosimilar Use
      • “Shifts in Drug Pricing Models”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today:
    • “The amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity is decreasing and has peaked in most regions of the country.
    • “Seasonal influenza activity is low.
    • “COVID-19 activity is low in most areas of the country.
    • “Nationally, wastewater activity levels for RSV, COVID-19 and influenza A are very low. Influenza B is not monitored in wastewater.”
  • The American Hospital Association News adds,
    • “The measles outbreak in Utah that began in June 2025 has grown to 638 cases as of May 5, according to the state’s Department of Health and Human Services. Of those, 441 have been reported this year. Nationally, there have been 1,842 confirmed measles cases in 2026, according to the Centers for Disease Control and Prevention. The vaccination status of 92% of cases is unvaccinated or unknown.”
  • Medscape reports,
    • “Once weekly semaglutide injections reduced alcohol consumption in patients with alcohol use disorder (AUD) and comorbid obesity.
    • “Results of the randomized controlled trial (RCT), the first, to the authors’ knowledge, to evaluate the GLP-1 receptor agonist (GLP-1RA) semaglutide in patients seeking treatment for AUD who had comorbid obesity also showed significant effects on multiple alcohol-related outcomes.
    • “These data, when added to the growing evidence, demonstrate the potential of GLP-1RAs as a novel treatment for alcohol use disorder,” the investigators, led by Mette Kruse Klausen, MD, Copenhagen University Hospital in Copenhagen, Denmark, wrote.
    • “However,” they added, “corroboration with larger RCTs in nonobese patients is needed to address its generalizability.”
  • and
    • “GLP-1 receptor agonists may alter absorption of oral medications due to delayed gastric emptying, affecting drug levels and efficacy. Notable interactions include oral contraceptives, levothyroxine, and dabigatran, necessitating careful monitoring and potential dose adjustments.”
  • Health Day relates,
    • “People recovering from surgery have an easy way to boost their odds of a successful recuperation — take a stroll.
    • “Every extra 1,000 steps a patient takes daily after surgery lowers their odds of complications, researchers reported May 6 in the Journal of the American College of Surgeons.
    • “This link between extra steps and better recovery applied across different types of procedures regardless of the patients’ overall health, researchers found.
    • “Researchers discovered this after tracking nearly 2,000 people undergoing inpatient surgery who wore activity trackers while undergoing inpatient surgery.”

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “UnitedHealthcare has begun paying some commercial claims instantly, bypassing the standard three to five day window associated with traditional ACH transactions, the insurer said May 4.
    • “Under the new system, eligible commercial claims payments are deposited immediately into providers’ bank accounts, with remittance data routed through clearinghouses to providers’ tax identification numbers.
    • “UnitedHealthcare did not specify which claims or plan types qualify for real-time payment. The payments are not processed through Optum and will not appear on the Optum Pay platform.
    • “Providers do not need to take action to receive the payments, but UnitedHealthcare said some may need to update reconciliation workflows.” 
  • Kaufmann Hall notes,
    • “Americans are increasingly making serious trade-offs that impact their health and daily lives to afford health expenses, according to a recent report from West Health-Gallup Center on Healthcare in America. About 30% of insured and 62% of uninsured Americans—across income brackets—have made at least one or more difficult trade-off: prolonging their prescription, skipping a meal, cutting back on utilities or borrowing money. A third reported postponing vacations and surgical and medical treatment alike. These trade-offs are not “nice to have.” Not taking medication as prescribed, skipping meals, cutting back on utilities especially during extreme weather, and delaying surgical and medical treatment carry serious medical risk for harm that leads to increased ED visits, readmissions, and other avoidable costly care that may impact hospitals and health systems.
  • MedCity News relates,
    • “As patient payment responsibility grows and becomes a larger part of the overall care experience, payment decisions need more visibility across the organization, not just in finance or IT. 
    • “Healthcare organizations should begin with a practical review that includes: which payment methods are accepted at every point of care, whether FSA, HSA, and Medicare card configurations are validated across systems, where declines are occurring and why, and how long it takes patients to move from statement to payment. 
    • “Payment friction isn’t always obvious. It shows up in extended accounts receivable timelines, increased billing inquiries, and patients who delay payment – not because they’re unwilling to pay, but because the process made it harder than it needed to be. As patients become responsible for more of the bill, consistency matters. The payment process should be predictable across settings and straightforward to navigate.
    • “Payment systems may not determine whether care is delivered. But as more financial responsibility shifts to patients, they increasingly influence how that care is experienced.”
  • Modern Healthcare tells us,
    • “Sanford Health is looking to expand its Minnesota network in one of the state’s fastest-growing regions. 
    • “Sanford and North Memorial Health signed a definitive agreement to add North Memorial’s two hospitals and affiliated facilities in northwest Minneapolis to Sanford’s 58-hospital footprint, according to a Friday news release. * * *
    • “Under the agreement, Sanford pledged to update emergency services at the financially strained safety-net hospital North Memorial Health Robbinsdale. Sanford also said it plans to help double the size of North Memorial Health Maple Grove Hospital by expanding emergency care, inpatient services, surgeries and labor and delivery care. 
    • “The proposed transaction is expected to close this year, pending customary regulatory approvals.”
  • Beckers Hospital Review points out,
    • “Between the fourth quarters of 2024 and 2025, emergency department length of stay decreased 13.4% even as volumes grew 4.2% and patient acuity rose, according to a May 6 report.
    • “The report is from Sg2, a healthcare analytics and consulting company at Vizient. Through its System of CARE Scorecard, Vizient measures hospital utilization, access, safety and cost efficiency each quarter. Its latest scorecard compared the fourth quarters of 2025 and 2024 for care coordination. 
    • “On a rolling year-over-year measure, ED length of stay declined 15.2% and volume increased 4.3%, according to the report. Vizient researchers hypothesized that improvements in throughput, shifting trends in patient mix or a combination of the two could be account for these findings.” 
  • Fierce Healthcare informs us,
    • “Amazon Pharmacy will make Novo Nordisk’s Ozempic pill available for home delivery, the company announced Thursday.
    • “Per the announcement, Amazon customers will be able to secure the oral GLP-1 medication via same-day delivery or pickup within minutes at its kiosks in short order. The drug, which is approved to manage blood sugar in individuals with type 2 diabetes, was originally sold as Rybelsus but was recently rebranded to Ozempic by Novo.
    • “Amazon said that making the drug available via its pharmacy will address “a critical access gap for the more than 36 million Americans living with type 2 diabetes.”
    • “Individuals with a prescription for oral Ozempic can order the drug through Amazon Pharmacy as well as access key availability and transparent pricing data, even if they are not Prime members, the company said. Pricing is as low as $25 per month with insurance coverage.”
  • The Wall Street Journal lets us know,
    • “Sandoz Group plans to launch its generic semaglutide in Canada and Brazil this year, following patent expiration in several countries.
    • “Sandoz Chief Executive Richard Saynor stated the generic weight-loss drug market size is unknown, with initial years focused on supply.
    • “Analysts forecast Sandoz’s generic semaglutide sales to reach $742.6 million in 2035, as the overall market expands.”
  • Per MedTech Dive,
    • “Stryker has completed the acquisition of Amplitude Vascular Systems, less than a month after the deal was announced. The financial terms were not disclosed.
    • “Amplitude has developed the Pulse intravascular lithotripsy platform to treat severely calcified arterial disease. The device uses pressure waves generated by carbon dioxide and delivered through a balloon catheter to fracture the calcium and expand narrowed vessels, restoring blood flow.
    • “Stryker said adding an IVL platform will strengthen its peripheral vascular portfolio, which includes the Inari Medical clot-removal business the company acquired last year for about $4.9 billion.”

Thursday report

David Ermer–FDA, Federal employment benefits, Generative AI, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Federal News Network reports,
    • “In the coming months, the Office of Personnel Management is expected to release a reworked version of its employee viewpoint survey that’s more focused on granular data and delivering realtime feedback.
    • “OPM Director Scott Kupor said his agency has been refining the survey to focus more on micro-level questions in order to more effectively gauge employee opinion.
    • “The goal is to get to a decision on what the kind of new survey format looks like so that we have time to do something over the course of this fiscal year for sure,” Kupor told Federal News Network in an interview Wednesday.”
  • Fedweek outlines the FEHB/PSHB eligibility rules for children.
    • “Both the Federal Employees Health Benefits program and Postal Service Health Benefits program, provide for coverage of spouses and children in their self plus one and family options. While enrollment changes typically happen during the open season each autumn, there are certain life events that involve adding children—for example from self plus one to self and family on the birth or adoption of a child.
    • “In both cases, it’s important to know who qualifies for coverage as a child, and when that may end.’
  • Thompson Reuters notes,
    • “QUESTION: We recall that the Affordable Care Act (ACA) requires insured group health plans to satisfy nondiscrimination rules similar to those that apply to self-insured plans under Code § 105(h) (the eligibility and benefit tests). What is the status of those rules? Are employers that sponsor insured plans required to comply with them, and if so, when?
    • “ANSWER: Under the ACA, insured group health plans generally must satisfy the nondiscrimination rules of Code § 105(h)(2), including “rules similar to” those in Code § 105(h) regarding nondiscriminatory eligibility, nondiscriminatory benefits, and controlled groups. The Code § 105(h) rules pre-date the ACA, prohibit certain discrimination in favor of highly compensated individuals, and apply only to self-insured health plans. The ACA applied similar requirements to insured plans, other than those that provide only excepted benefits or qualify for grandfathered status.
    • “Although insured group health plans initially were required to comply with the ACA nondiscrimination rules for plan years beginning on or after September 23, 2010, the IRS announced in Notice 2011-1 that compliance is not required until the agencies issue regulations or other guidance regarding how the rules apply to insured plans. To date, the agencies have not issued such regulations or guidance, so sanctions for failure to comply do not yet apply for insured plans. Note that the Code § 105(h) nondiscrimination rules continue to apply to self-insured health plans, including those that provide excepted benefits or are grandfathered. For example, the Code § 105(h) nondiscrimination rules continue to apply to health FSAs”.
  • Per an HHS news release,
    • “Today, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced an Interim Final Rule (IFR) extending, for one-year, the compliance dates that recipients of HHS funding must meet for conforming web content and mobile applications to specific accessibility standards under Section 504 of the Rehabilitation Act of 1973 (Section 504).
    • “Under the revised timeline:
      • “Recipients with 15 or more employees will now have until May 11, 2027, to comply.
      • “Recipients with fewer than 15 employees will now have until May 10, 2028, to comply.

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “After a surprise rejection at the beginning of 2026, the FDA has agreed to reconsider a T-cell therapy based on the same single-arm trial that the agency had previously found problematic.
    • “For Pierre Fabre Pharmaceuticals and Atara Biotherapeutics’ Ebvallo, the FDA agreed during a recent meeting that a single-arm study using an appropriate historical control “could serve as an adequate and well controlled study” in support of an application for approval, the two companies said Thursday.
    • “Pierre Fabre and Atara are aiming to get Ebvallo, also known as tabelecleucel or tab-cel, approved for patients with relapsed or refractory Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+PTLD) who have failed on an anti-CD20 regimen. Before the FDA, European regulators had already greenlighted the immunotherapy for the indication in 2022.”
  • MedPage Today adds,
  • and
    • “An investigational trivalent mRNA-based vaccine reduced confirmed flu illness by 26.6% through the end of the flu season compared with approved standard-dose vaccines in a randomized trial among adults ages 50 and older.
    • “The mRNA vaccine led to more adverse events, particularly injection-site pain and fatigue, but most were transient and mild without an excess of more serious risks.
    • “An FDA decision on approval is expected by August.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “Using the blood of a 56-year-old woman vaccinated against measles, scientists have isolated a fighting force of four potent virus-blocking antibodies that could pave the way toward a treatment for people exposed to the highly contagious respiratory disease making a comeback in the United States.
    • “A safe, highly effective vaccine for measles has been available since the 1960s, and the U.S. officially eliminated the disease in 2000, with sporadic cases and outbreaks. But dropping vaccination rates have sparked large outbreaks in multiple states, and the country is edging closer to the virus spreading freely again—which puts more people at risk.
    • “New ways to block or treat measles would be particularly important for people who are immunocompromised and babies under the age of 1, because they are not eligible for the vaccine, leaving them unprotected amid a growing number of cases.
    • “Measles was a problem that was solved. Until it wasn’t solved anymore,” said Erica Ollmann Saphire, president of the La Jolla Institute for Immunology who led the study published Thursday in the journal Cell Host & Microbe. But she and other scientists stressed that this approach was not a substitute for a vaccine.
    • “The treatment is always going to be more expensive than the vaccine. It’s the best bang for your public-health buck — this is for people that couldn’t be vaccinated,” Saphire said.”
  • MedPage Today adds, “A new systematic review in The BMJ reported that current evidence did not support causal associations between aluminium adjuvanted vaccines and serious or long-term health outcomes.“
  • Infectious Disease Advisor notes,
    • “HIV pre-exposure prophylaxis (PrEP) uptake remains suboptimal among commercially-insured adolescents and young adults in the United States, highlighting the need for targeted interventions to address access barriers.”
  • The American Medical Association lets us know what doctors wish their patients knew about swimmer’s ear.
    • “Diving into pools or spending the day at the beach or lake can be the epitome of summer fun, but these aquatic adventures can also come with an unwelcome companion: otitis externa, commonly known as swimmer’s ear. This common affliction can sideline even the most dedicated water enthusiasts with its painful consequences. With the incidence of swimmer’s ear rising during the warmer months, understanding its causes, symptoms and prevention methods is essential for water enthusiasts of all ages.” 
  • The National Institute for Health Care Management’s May newletter discusses “Cancer Trends & Treatment Advancements”
  • Per BioPharma Dive,
    • “CellCentric, a biotechnology company developing an experimental drug for multiple myeloma, announced Wednesday it raised a $220 million Series D round to finance mid- and late-stage trials.
    • “Its lead drug, dubbed inobrodib, is an oral medicine that blocks a pair of proteins called “p300” and “CBP,” which in turn prevents the expression of certain key cancer-driving genes. CellCentric believes the treatment might be useful as an additive therapy across different lines of care in multiple myeloma. 
    • “The biotech is testing inobrodib in an all-oral combination involving Bristol Myers Squibb’s Pomalyst, as well as in conjunction with bispecific antibodies for myeloma such as Pfizer’s Elrexfio and Johnson & Johnson’s Tecvayli. It’s also evaluating use in a “maintenance” setting, where treatments are used to keep cancer from returning.”

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “Blue Shield of California debuted its virtual-first Virtual Blue healthcare plan just over three years ago. Now, the data is rolling in.
    • “The program began in 2023 through a collaboration with tech-enabled healthcare platforms Accolade — now owned by Transcarent — and TeleMed2U. The program has no out-of-pocket costs for visits with virtual-only providers, can often deliver same-day care and now has more than 150,000 members. Blue Shield is even tacking virtual primary care options onto its Trio HMO plan, expanding offerings into the individual market.
    • “Tim Lieb, Blue Shield of California’s senior vice president of commercial markets, recently joined the “Becker’s Payer Issues Podcast” to discuss Virtual Blue’s early strengths and challenges.”
  • Healthcare Dive relates,
    • “Nearly 8 in 10 employers report GLP-1 drugs are driving heightened healthcare costs at their companies, pushing some to consider dropping coverage of the pricey weight loss medications, according to a survey released Tuesday by the Business Group on Health.
    • “Only 72% of employers that cover GLP-1s for weight management said they’d likely maintain that coverage next year, while 10% reported they likely wouldn’t, according to the group, which represents employers that provide health coverage. 
    • “Additionally, 87% of respondents said new oral versions of GLP-1 drugs would result in higher demand for the medications, but only 9% predicted prices would decrease.”
  • and
    •  Providing hospital-level care in patients’ homes was linked to better clinical outcomes, suggesting hospital-at-home programs could serve as a safe and efficient alternative to traditional inpatient care, according to a study published this week in JAMA Network Open. 
    • Hospital at home was associated with decreased emergency department use within 30 days of discharge and lower in-hospital mortality, according to the research. But patients at hospital-at-home programs saw no significant difference in hospital readmissions within 30 days. 
    • Additionally, adoption of hospital at home across the country is uneven, with few rural facilities participating, researchers wrote. The findings “underscore the need to address practical and implementation challenges to broaden equitable access,” they said.
  • Per Healthcare Cost Institute news releases,
    • Health care spending can differ dramatically depending on where Americans live, with costs varying by more than twofold from one metro area to another, according to new findings from the Health Care Cost Institute (HCCI). Charleston, WV, tops the list of the highest spending markets, with annual costs more than twice those in places like Bakersfield, CA, one of the country’s lowest spending areas.
    • The new data comes from the Health Cost Landscape, HCCI’s updated interactive platform that compares health care spending, prices, service use, and market dynamics across 269 metro areas in 45 states. The tool gives a clear, local look at how health care markets function and where consumers are paying the most for care.
  • and
    • “The Transparency in Coverage (TiC) regulations have introduced unprecedented visibility into negotiated health care prices in the United States. By requiring insurers to publish machine-readable files containing payer–provider contracted rates starting in 2022, the policy has created a new data source for studying price variation. However, the scale, inconsistency, and missing information within the TiC data mean that rigorous methodological work is required before it can be used for research. This brief explores the nature of this data, how it is accessed and processed, and how it can be used for analysis, with a detailed walkthrough of a real example examining childbirth prices in Pennsylvania.” * * *
    • “Transparency in Coverage data represent a significant advancement in the availability of information on negotiated health care prices, offering researchers a new lens into variation across payers, providers, and markets. As demonstrated in the childbirth analysis in Pennsylvania, TiC data can be used to replicate and extend findings from traditional claims-based research, particularly in understanding the range and distribution of negotiated rates across payers and providers.
    • “At the same time, the value of TiC data depends heavily on the methods used to create an analytic dataset. The raw data are not inherently research-ready and require substantial processing, including careful service definition, data cleaning, provider and payer entity resolution, and restrictions to ensure comparability. Without these steps, analyses may not be replicable and risk reflecting the messiness of the raw data rather than meaningful differences in prices. Additionally, the absence of utilization data remains a fundamental limitation, requiring integration with external sources to fully assess spending and average prices.
    • “Overall, TiC data should be viewed as a powerful but incomplete resource. When used appropriately, they can provide important insights into health care pricing dynamics and market structure. As data quality improves and methods continue to evolve, TiC data are likely to become an increasingly valuable complement to claims data in health services research.”
  • Per Fierce Healthcare,
    • “Hims & Hers launched an artificial intelligence agent embedded in its platform to help interpret biomarker lab results and provide users personalized insights about their health.
    • “The company launched its direct-to-consumer lab testing program for health biomarker testing back in November. The new agent AI, Labs AI, has been available to some customers in beta testing and will roll out to all Labs customers over time, the company announced Thursday.
    • “Hims & Hers’ Labs offers access to 130 biomarker tests across 10 health areas, including heart health, metabolism, hormones, inflammation and stress, as part of its strategy to extend into prevention and health screening. The new AI care agent makes customers’ lab results clearer, more useful and easier to engage with, according to Patrick Carroll, M.D., Hims & Hers chief medical officer.”
  • and
    • “Ardent Health topped the market’s revenue and earnings estimates, touting Wednesday solid adjusted admission and labor spend numbers despite what has proved to be a tumultuous first quarter for hospitals. 
    • “The publicly traded for-profit logged $1.6 billion of total revenue, which was up 7% year over year and 1.3% above Zacks Investment Research’s consensus estimate. Net income was $40 million, or 28 cents per share, beating the consensus estimate of 18 cents per share. 
    • “Similar to other for-profit health systems’ reports from the past few weeks, executives acknowledged the impacts of a weak respiratory season and severe winter storms on Ardent’s business, particularly in Texas, Oklahoma and New Jersey. That led to a 1.1% year-over-year decline in admissions, though CEO Marty Bonick said during Wednesday’s earnings call that the company “acted swiftly to reschedule surgeries and adjust labor to align with volume, mitigating the impact on our performance.”
  • Per Fierce Pharma,
    • “With an eye on the lucrative U.S. market, Italy’s Angelini Pharma will acquire rare disease specialist Catalyst Pharmaceuticals and its potential blockbuster, Firdapse, for $4.1 billion.
    • “Rome-based Angelini, a family-owned private company established in 1919, is paying $31.50 per share for Florida-based Catalyst. It is a 3% premium on Catalyst’s share price at close yesterday and a 21% premium on its price on April 22 before market activity hinted at public knowledge that a sale was in the offing. Bloomberg reported the potential buyout on April 27, triggering another stock surge.”
  • Per MedTech Dive,
    • “Roche has agreed to acquire PathAI, a Boston-based digital pathology firm, for up to $1.05 billion.
    • “Roche plans to pay $750 million upfront and up to $300 million in additional milestone payments, according to a Thursday announcement. 
    • “The acquisition is expected to close in the second half of 2026, subject to customary closing conditions, including antitrust and regulatory approvals.”

Midweek update

David Ermer–CDC, CMS, FDA, Generative AI, Medical / Rx research, Medicare, Patient safety, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC,

  • The American Hospital Association News tells us,
    • “The White House May 4 released its National Drug Control Strategy, which, among other efforts, recommends effective primary prevention programs. The initiative increases the implementation of evidence-based prevention strategies; establishes new partnerships with organizations supporting youth health and expanding primary prevention; supports a national media and education campaign against drug use; and supports and enhances the federal drug-free workplace program.”
  • The Centers for Medicare and Medicaid Services announced,
    • “The Centers for Medicare & Medicaid Services (CMS) will provide eligible Medicare beneficiaries access to certain GLP-1 medications for $50 per month beginning July 1, 2026, through December 31, 2027.
    • “Under the Medicare GLP-1 Bridge, a time-limited demonstration, CMS is expanding access to innovative, evidence-based weight-loss treatments. Eligible individuals enrolled in Medicare Part D prescription drug plans will be able to access these medications at a predictable and affordable cost—$50 for a monthly supply. This approach reflects CMS’ continued focus on improving access to high-value treatments that support better long-term health outcomes.
    • * * * “Beginning July 1, Medicare beneficiaries with Part D coverage may be eligible to access certain GLP-1 medications at $50 for a monthly supply. Beneficiaries can talk to their doctor to determine whether a GLP-1 medication is right for them. CMS will share additional information for beneficiaries as the program begins.
    • “In addition, CMS continues to work with stakeholders—including providers, pharmacies, and manufacturers—to support implementation and ensure all partners have the information they need ahead of launch. 
    • “The Medicare GLP-1 Bridge builds on CMS’ broader efforts to improve access to innovative therapies and support healthier outcomes for Medicare beneficiaries. For additional “demonstration details, visit: https://www.cms.gov/medicare/coverage/prescription-drug-coverage/medicare-glp-1-bridge
  • U.S. Office of Personnel Management Director Scott Kupor, writing in his Secrets of OPM blog on Substack, optimistically discusses the state of artificial intelligence.
  • Meanwhile, KFF Health News reviews “Regulation of AI in Prior Authorization and Claims Review: A Look at Federal and State Consumer Protections.”

From the Food and Drug Administation front,

  • Per FDA news releases,
    • “The U.S. Food and Drug Administration today announced major steps in its bold initiative to modernize the agency. The agency launched Elsa 4.0, a significant upgrade to the agency’s internal AI tool available to all FDA staff, from scientific reviewers to investigators.  
    • “The agency also consolidated more than 40 disparate application and submission data sources, systems and portals across all FDA centers into a new platform called HALO (Harmonized AI & Lifecycle Operations for Data).The agency began integrating HALO and Elsa so that FDA staff can query data and build workflows without having to manually upload documents within each chat. The HALO consolidation is expected to enable more penetrating deployment of AI capabilities within agency operations. 
    • “Elsa’s new capabilities once again position FDA as a leader in deploying AI tools that empower staff,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Removing tedious burdens for staff enables them to focus more on science and makes their work streams more efficient and enjoyable. We have some of the best scientists in the world and we need to take good care of them.”
  • and
    • The U.S. Food and Drug Administration today announced that it is piloting one-day inspectional assessments, as part of a broader initiative to make its inspectional resources more targeted and efficient. As part of this pilot, which launched in April, the agency is conducting shorter, focused screening assessments to complement standard FDA inspections. 
    • “One-day inspections can strengthen our inspectional approach by focusing our time and resources where they are most needed—enhancing our overall effectiveness,” said FDA Commissioner Marty Makary, M.D., M.P.H. “For the FDA, the ability to conduct shorter, targeted assessments allows for broader surveillance coverage, enabling the agency to assess more facilities and gather critical insights without compromising regulatory rigor. For industry, these assessments can provide timely feedback while minimizing operational disruption, particularly for lower-risk establishments.”
    • One-day inspectional assessments also support the development of more robust risk models across FDA programs. Data gathered through these assessments—such as recurring compliance themes, facility-specific risk scores, and discrepancies between registered and actual operations—can be used to better target future oversight activities.
  • MedTech Dive tells us,
    • “The Food and Drug Administration added neurosurgical supplies to its medical device shortages list on Wednesday.
    • “The regulator sent a letter to healthcare providers warning about disruptions in availability of neurosurgical patties, sponges and strip devices, which are used to absorb fluids and protect tissue during surgery.
    • “The FDA attributed the problem to recent supplier issues, noting that Medline Industries recently recalled its neuro sponge products. The agency expects the shortage to continue through the end of the year.”

From the public health and medical / Rx research front,

  • The New York Times explains,
    • “Hantaviruses have most likely been around as long as rodents, but little was known about these pathogens before the 20th century. This rare family of viruses that rodents carry has been cited as the source of a deadly outbreak aboard a cruise ship in the Atlantic Ocean.
    • “The virus is zoonotic, meaning it can be transmitted to humans from animals. And while outbreaks have been rare, it is one of the most widely distributed zoonotic viruses on Earth.
    • “Some are Old World hantaviruses and others are New World hantaviruses,” said Sabra Klein, a professor of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health.
    • “Different species of the virus are carried by different rodents,” Dr. Klein said, adding that European strains cause less severe illnesses than those from Asia.
    • She noted that “there’s no vaccine, there’s no cure, there’s no money” in finding a cure “in part because these are so rare.”
  • The Wall Street Journal adds,
    • “Hantavirus is an unlikely source of contagion on a cruise ship. The virus isn’t as infectious between humans as fast-spreading respiratory illnesses like Covid-19 and the flu. 
    • “It belongs to a family of viruses carried by rodents and spread to humans through contact with infected urine, droppings or saliva. Only one strain—the Andes virus—has shown limited evidence of human-to-human transmission. Researchers in South Africa and Switzerland confirmed this week the virus involved in the suspected outbreak is the Andes strain.
    • “Human-to-human transmission of the Andes strain requires very close contact, like sharing food or living quarters, according Steven Bradfute, an immunologist at the University of New Mexico Health Sciences Center whose lab has sequenced hantaviruses. “It doesn’t spread into huge outbreaks,” Bradfute said.
    • “WHO and other health authorities say the threat to public health is low. 
    • “Yet the ship’s passengers are at risk, as well as perhaps people they came into close and extended contact with after leaving the ship. That is why Oceanwide Expeditions, the Hondius’s operator, plus health authorities around the world and airlines, are mobilizing to trace the paths of the ship’s travelers.”
  • Fierce Healthcare reports,
    • “The Leapfrog Group highlighted broad improvements across several patient safety measures in this year’s spring release of hospital safety grades, the first reflecting changes made after a court-ordered removal of hospitals that declined to voluntarily submit information to the watchdog group. 
    • “Top marks were handed out to 917 hospitals, with Leapfrog outlining a particularly high share of “A” hospitals in the states of Connecticut (where 64% of hospitals received an “A”), Virginia (59%), South Carolina (51%), Utah (50%) and Montana (44%). 
    • “A hospital’s assigned grade is calculated by reviewing recent data on up to 22 patient safety measures, including a 10-part Medicare composite of reported patient safety and adverse events. Among these, Leapfrog said it saw “significant improvement” in 17 measures, including those related to healthcare-associated infections and medication safety plus multiple items related to patient experience. 
    • “The good news is that hospitals across the country are making meaningful strides in patient safety and helping save countless lives,” Leah Binder, president and CEO of The Leapfrog Group, said. “But not all hospitals are the same. That’s why it’s so important for people to consult Safety Grades and do their research when choosing a hospital.”
    • “Of note, the latest release excludes 450 hospitals that did not participate in Leapfrog’s 2024 or 2025 surveys.” 
  • Beckers Hospital Review points out the “eleven U.S. hospitals have earned consecutive “A” safety grades from The Leapfrog Group since 2012.” You can see “the list of Leapfrog’s five “F” hospitals here.
  • Pulmonary Advisor notes,
    • “While vaccinations showed protective trends, prior viral infections were generally linked to an increased likelihood of future respiratory illnesses.”
  • Per MedPage Today,
    • “Updated findings from a European randomized trial continued to show that colonoscopy screening significantly reduced colorectal cancer (CRC) incidence, but its impact on CRC mortality was less clear.”
  • Following up on recent Wall Street Journal articles, Cardiology Business relates
    • “Three of the leading U.S. cardiovascular health societies have joined forces for a new statement about the importance of multidisciplinary, patient-centered decision-making when managing patients with severe aortic stenosis (AS).
    • “The Society for Cardiovascular Angiography and Interventions (SCAI), American College of Cardiology (ACC) and Society of Thoracic Surgeons (STS) collaborated on the joint statement, calling it a response to “recent media coverage” about transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). The primary focus of the statement appears to a feature story published by The Wall Street Journal on April 23 that included interviews with patients who experienced significant complications after undergoing TAVR. 
    • “The joint statement highlights the fact that multidisciplinary heart teams are at the center of every treatment decision for patients who present with severe AS and require an aortic valve replacement. This has been the case for many years now, but coverage from The Wall Street Journal and other mainstream news outlets is sure to grab the attention of people unfamiliar with how such treatment decisions are made. 
    • “This statement serves as a fresh reminder for the general public that cardiologists and cardiac surgeons do not take these decisions lightly. The cardiology groups said years of hard work and dedication have gone into developing the framework that is now in place.”
  • Per MedTech Dive,
    • “Neptune Medical’s gastrointestinal robot met both of its primary endpoints in a clinical trial assessing the safety and feasibility of the system to perform colonoscopies.
    • “The study followed 50 adults who underwent screening, surveillance or diagnostic colonoscopy with the robotic endoscopy system at a single center in Poland for 14 days after the procedure.
    • “The results, announced Tuesday, showed no adverse events and a 100% rate of cecal intubation, where the endoscope is guided through the entire colon to the beginning of the large intestine.”
  • and
    • “Johnson & Johnson said Tuesday that a study evaluating the investigational Ottava robotic system in gastric bypass surgery met its safety and efficacy endpoints through 30 days. The average weight loss in that time frame was 30 pounds.
    • “Results from the 30-patient study were among the pre-clinical evidence included in J&J’s submission to the Food and Drug Administration, announced in January, for de novo classification of the robot in multiple procedures in the upper abdomen. 
    • “All procedures in the prospective, multicenter study were completed robotically on Ottava without conversion to a non-robotic approach, the company said. There were no adverse events related to the device.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “CVS Health exceeded first-quarter earnings expectations and raised its full-year adjusted-earnings guidance.
    • “The company reported first-quarter net income of $2.96 billion, driven by a turnaround at its Aetna insurance unit.
    • “Aetna’s medical-loss ratio was 84.6%, below analysts’ projections, but 2027 Medicare rates still fall short.”
  • Modern Healthcare relates,
    • “Humana plans to cut Medicare Advantage supplemental benefits in 2027 in a strategic shift for the insurer.
    • “Medicare Advantage payments are not keeping pace with medical costs, President and CEO Jim Rechtin said.
    • “Medicare Advantage membership was 22.6% higher in the first quarter.
    • “Humana downgraded its annual earnings guidance.”
  • Beckers Payers Issues tells us,
    • “Oscar Health reported a net income of $679 million in the first quarter of 2026, according to a May 6 earnings release. This marked the highest quarterly profit in the company’s history, nearly 2.5 times greater than profit in the first quarter of 2025.
    • “Membership reached roughly 3.2 million members, a 56% year-over-year increase. The company’s medical loss ratio was 70.5%, compared to 75.4% during the same period last year.
    • “Total revenue reached $4.6 billion, up 53% year over year. Earnings from operations were $704.1 million, more than double from the first quarter of 2025.
    • “The company also reaffirmed its 2026 guidance. The strong quarter follows a $443 million net loss in 2025.”
  • Fierce Healthcare informs us,
    • “Hinge Health boosted its full-year revenue outlook by $64 million as the company reported a stronger-than-expected first quarter and kicked off an expansion of its business beyond muscle and joint pain.
    • “The digital musculoskeletal (MSK) care provider, which went public nearly a year ago, brought in first-quarter revenue of $182 million, up 47% year-over-year from $123.8 million in Q1 2025. The company posted first-quarter adjusted earnings of 45 cents per share, significantly exceeding Wall Street analyst estimates of 12 cents per share. Hinge Health’s non-GAAP income from operations jumped 208% to $46.2 million compared to non-GAAP income from operations of $15 million during the same quarter a year ago.
    • “The company’s results easily topped Wall Street analyst estimates, with a revenue target of $172 million for the quarter and a Street estimate of $31.2 million for operating income.”
  • and
    • “Amwell, the telehealth platform formerly known as American Well, brought in $54.9 million in first-quarter revenue, down approximately 18% the same period a year ago, as executives discussed artificial intelligence and key contract renewals with investors on Tuesday.
    • “The company is shifting towards subscription revenue, and in Q1, subscription software revenue was 53% of total revenue at $24.9 million, which Chief Financial Officer Mark Hirschhorn said was down “approximately 23%” year-over-year in a May 5 call to discuss Q1 results. 
    • “Encouragingly, renewals and retention were higher than budgeted in the first quarter, providing greater confidence in the stability of our subscription base going forward,” Hirschhorn said.
    • “Amwell’s visit volume was down approximately 19% compared to a year ago, according to Hirschhorn, with 1.1 million visits in Q1. Hirschhorn said the figure is “is in line with the portfolio changes” previously disclosed by the company.”
  • The Wall Street Journal lets us know,
    • “BioNTech plans to shrink its workforce and manufacturing network to cut costs after Covid-19 vaccine demand waned.
    • “The company will affect 1,860 roles, about 22% of its 8,400-person workforce, and exit manufacturing plants.
    • “BioNTech will hand Covid shot supply to Pfizer, pivot to cancer therapies, and projects 500 million euros in annual savings by 2029.”
  • and
    • “Bayer agreed to acquire Perfuse Therapeutics, an eye disease drug specialist, for up to $2.45 billion.
    • “The acquisition aims to complement Bayer’s ophthalmology pipeline, following patent expiration issues with its Eylea drug.
    • ‘Perfuse’s lead drug candidate is an experimental treatment for glaucoma and diabetic retinopathy in mid-stage trials. Bayer will pay $300 million upfront.”
  • Per Fierce Pharma,
    • “Since the start of the decade, Eli Lilly has committed to spend more than $50 billion to bolster its United States manufacturing capabilities. But even that’s not enough to meet the needs of the rapidly growing pharma giant.
    • “On Wednesday, Lilly said that it has earmarked another $4.5 billion to further build up two of three planned production facilities in Lebanon, Indiana, some 28 miles northwest of Lilly’s headquarters in Indianapolis. The company revealed the new investment at a ribbon cutting ceremony for its genetic medicine plant in Lebanon, the first of the three new facilities at the site to become operational.
    • “Of the sum Lilly has pledged to spend for its domestic manufacturing in this decade, more than $21 billion has been allocated for the buildup in its home state. Lilly’s “evolving pipeline” and shifts in the anticipated demand for its products dictated the additional funding, the company said.”





Tuesday report

David Ermer–CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Fierce Healthcare reports,
    • “Another top Republican lawmaker is floating plans to overhaul the Current Procedural Terminology, or CPT, code system. 
    • “Rep. James Comer, R-Kentucky, who chairs the House Committee on Oversight and Government Reform, penned a letter late last week to the Centers for Medicare and Medicaid Services seeking information on the CPT code system’s complexity and whether its structure is facilitating improper billing such as upcoding or unbundling. 
    • “Further, he asked the agency to describe “any constraints—statutory, regulatory or operational—that limit CMS’ ability to modify or move away from the current CPT-based system.” 
    • “The questions come as one of Comer’s colleagues in the Senate Health, Education, Labor and Pensions (HELP) Committee Chair Bill Cassidy, M.D., R-Louisiana, has placed a magnifying lens on the American Medical Association (AMA) over the millions in revenue it collects managing, and advising on, the CPT code system (see that coverage below the break).
    • “Comer’s approach was less combative, and his letter to CMS does not directly place blame on the AMA. Still, it notes that Medicare and Medicaid’s codified use of the association’s proprietary system “raises concerns about federal reliance on a privately owned and licensed coding system. These concerns include fundamental questions about transparency, cost control, and whether federal healthcare policy is shaped in the best interest of patients, or by entities with financial incentives tied to the system’s continued complexity.” 
  • Kevin Moss, writing in Govexec, “weighs the costs and trade-offs of suspending FEHB for Medicare Advantage.”
  • CMS Administrator Dr. Mehmet Oz lets us know,
    • “Last year, the U.S. Department of Health and Human Services and the Centers for Medicare & Medicaid Services (CMS) announced a landmark pledge with major health plans from across the country to streamline and improve the prior authorization process across the entire health care industry. This pledge reflects a shared commitment to modernizing prior authorizations to create a more responsive, patient-centered experience. 
    • “Since then, the health care industry has already begun delivering results. For example, leading health plans announced in April that they eliminated 11% of prior authorizations across a range of medical services, representing 6.5 million fewer prior authorizations for patients. Other plans are rapidly scaling standardized processes and reducing requirements, demonstrating that meaningful change is not only possible—it’s happening. For example, one large national plan is eliminating authorization requirements for 30% of healthcare services and has committed to removing an additional 30% of remaining requirements by the end of 2026. 
    • “CMS is proud to announce the next chapter of that commitment: adding electronic prior authorization to the Health Tech Ecosystem. The initial landmark pledge effort brought the nation’s major health plans to the table. This new initiative brings everyone else. Health systems, hospitals, physician practices, electronic health record (EHR) vendors, and digital health developers are now joining payers as a unified coalition aligned around a single mission: making electronic prior authorization work end-to-end, on time, for every patient.” 
  • The Wall Street Journal adds,
    • “UnitedHealth Group plans to stop requiring doctors to get approvals for an array of procedures, tests and services, cutting back on a process that has long been detested by physicians and patients.
    • “UnitedHealth, parent of the biggest U.S. health insurer, said the changes will slash the number of reviews by nearly a third starting later this year. Doctors have long complained about the paperwork they must complete to get insurers’ permission for care, which can lead to delays and denials.
    • “UnitedHealthcare will stop requiring signoffs for tests including echocardiograms, some chiropractic care and certain outpatient surgeries. Also on the list is some outpatient therapy.
    • “The insurer said it is using technology backed by artificial intelligence to help reduce the need for pre-authorization reviews.
    • “The rollback is part of an effort by health insurers to counter a backlash against pre-authorizations. Rivals like CVS Health’s Aetna and Cigna Group have also made moves to ease these types of reviews.”
  • Per an HHS news release,
    • “The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today announced the launch of its Intelligent Generator of Research (IGoR) program, a systemic effort to deliver gold-standard biomedical science faster. The program will accelerate breakthroughs with a next-generation, AI-powered research ecosystem built to expand the experimental capabilities available to researchers. Crucially, the system will continuously refine advanced models of complex and chronic health conditions that impose a growing burden on Americans and the U.S. health system.” * * *
    • “For centuries, intrepid scientists have discovered amazing insights about health and disease. Yet, as frontier problems become more complex, the speed of discovery has been limited by what information and experimental capabilities are at researchers’ fingertips,” said IGoR Program Manager Paul E. Sheehan, Ph.D. “Through ARPA-H’s new IGoR program, we can amplify human creativity by reimagining the research ecosystem and empowering our scientists to answer ever more challenging questions about medicine’s unsolved mysteries.”
    • “The IGoR program will span 5 years. ARPA-H will solicit proposals under its Innovative Solutions Opening (ISO) and encourages collaboration among experts across disciplines to meet the program’s ambitious goals.” * * *
    • “For more information, including solicitation details and Proposers’ Day registration for this funding opportunity, visit the IGoR program page.”

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration (FDA) today authorized the marketing of four Glas electronic nicotine delivery systems (ENDS) through the premarket tobacco product application (PMTA) pathway. Each product is an e-liquid pod containing 50mg/ml (or 5%) of tobacco-derived nicotine. The authorized pods include Classic Menthol, Fresh Menthol, Gold, and Sapphire. This action marks the FDA’s first authorization of non-tobacco and non-menthol ENDS products.
    • “Smoking is the leading preventable source of chronic disease and premature death in the U.S. Last year, one in five deaths resulted from cigarette smoking.  More than 25 million Americans External Link Disclaimer still smoke combustible cigarettes, and they deserve better, less harmful alternatives. Under President Trump’s leadership, the FDA has authorized a number of less harmful alternatives for smokers, including 11 ENDS products from American companies.”

From the judicial front,

  • Modern Healthcare reports,
    • “A California hospital trade group sued to stop Elevance Health from implementing a policy that would cut payments to hospitals that refer some members to out-of-network providers. 
    • “In a complaint filed Monday in the state Superior Court of Los Angeles County, the California Hospital Association contended the policy allegedly violates state consumer protection and healthcare laws.” * * *
    • “Starting in June, Elevance Health plans to reduce California hospitals’ payments by up to 10% if they refer commercial patients to out-of-network physicians. 
    • “The Blue Cross Blue Shield licensee has introduced similar versions of the policy in at least 12 other states where it operates Anthem Blue Cross Blue Shield commercial plans. 
    • “The policy is intended to lower commercial healthcare costs, an Elevance Health spokesperson said in a statement. The spokesperson also said some out-of-network providers abuse the federal arbitration process enacted under the No Surprises Act of 2020.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “The World Health Organization said human-to-human hantavirus transmission is possible on a cruise ship.
    • “A suspected hantavirus outbreak on the MV Hondius led to three deaths and four other infections among 147 people on board.
    • “The WHO assumes the hantavirus is the Andes variant, known in Argentina, where initial patients boarded the ship.”
  • The New York Times lets us know what doctors want you to know about cannabis and health.
    • “The government recently loosened medical marijuana rules. Experts separate fact from fiction about the drug’s safety and benefits.”
  • MedPage relates,
    • “New research is raising alarms about inhalants, which are often portrayed online as harmless while putting teens at real risk.
    • “Two new studies point to a troubling pattern: Younger teens, especially girls, may be more vulnerable — and social media is a major source of exposure.
    • “In one study, recently published in the Journal of Studies on Alcohol and Drugs, researchers reviewed 30 videos about nitrous oxide — often called “laughing gas” — posted in early 2025.
    • “Those videos averaged 23 million views. Some showed how to use it, with no age restrictions or health warnings. Others promoted “free trials” of nitrous oxide products, highlighting how easy and accessible these substances can be for teens.
    • “Inhalants remain one of the least-studied and least-discussed substance-use categories, despite the seriousness of their health risks,” said lead author Rachel Hoopsick, an assistant professor of health and kinesiology at the University of Illinois Urbana-Champaign.”
  • and
    • “Maternal respiratory syncytial virus (RSV) vaccination and infant nirsevimab immunization, administered alone or sequentially, are safe and effective, according to a study published online May 4 in Pediatrics.
    • “Christina A. Rostad, M.D., from the Emory University School of Medicine in Atlanta, and colleagues conducted a randomized, open-label phase 4 study at eight U.S. sites of mother-infant pairs to examine administration of maternal RSV prefusion F vaccination (RSVpreF) and infant nirsevimab immunization. Pairs were randomly assigned during pregnancy to receive maternal RSVpreF vaccine alone, maternal RSVpreF vaccine/infant nirsevimab at birth, maternal RSVpreF vaccine/infant nirsevimab at 3 months, or infant nirsevimab alone at birth. To ascertain safety, infant tolerability, and the magnitude and durability of RSV-A and B neutralizing antibodies (nAbs), pairs were followed for 12 months.”
  • MedPage Today adds,
    • “Older U.S. adults who received the recombinant shingles vaccine had a lower incidence rate of dementia than their peers.
    • “Receiving the recombinant zoster vaccine also was linked to reduced risks of Alzheimer’s disease and vascular dementia.
    • “The analysis assessed dementia risk with the current two-dose shingles shot in the U.S., unlike other research.”
  • and
    • “Over 6 years, about 30% of people with pure autonomic failure converted to Parkinson’s, dementia with Lewy bodies, or multiple system atrophy.
    • “The incidence rate for general conversion, 5.1 per 100 person-years, far exceeded rates in the general population.
    • “The findings were based on a meta-analysis of nine studies that included 900 people with confirmed pure autonomic failure.”
  • Genetic Engineering and Biotechnology News informs us,
    • “Tracking microbes is challenging, particularly when there are coexisting strains of the same species within metagenomic data. However, overcoming that challenge is important for inferring transmission of both pathogenic and commensal microbes.
    • “A new tool, called TRAnsmision Clustering of Strains (TRACS), distinguishes between closely related bacterial strains. The “highly accurate algorithm” can be used for “estimating genetic distances between strains at the level of individual single nucleotide polymorphisms, which is robust to intra-species diversity within the host.”
    • “Researchers used the TRACS tool to map the transmission of SARS-CoV-2, Streptococcus pneumoniae, and Plasmodium falciparum (the causative agent of malaria) across different populations. The tool may play an important role in infection prevention, outbreak response, and the development of treatments designed to help the human microbiome fight infection. They note that this tool can be used across microbial kingdoms to uncover strain dynamics.”
  • STAT News points out,
    • “A closely watched therapy developed by Johnson & Johnson failed to show a statistically meaningful improvement for patients with inflammatory bowel disease. But the company plans to advance the drug into late-stage testing, focusing on a growing subgroup of patients. 
    • “On Tuesday, trial investigators presented the results of Johnson & Johnson’s DUET study, testing how well combining the drugs Tremfya and Simponi would stop the immune system from mistakenly attacking healthy tissues in the digestive tract. It’s a follow-up to a 2022 clinical trial that showed a significant benefit to patients, nearly doubling the rates of disease remission and spurring several companies to start developing combination approaches for IBD. 
    • “Johnson & Johnson tested its combined therapy, dubbed JNJ-4804, in two Phase 2b clinical trials hitting both major forms of inflammatory bowel disease — ulcerative colitis and Crohn’s disease. In each trial, the combination therapy performed better than the individual drugs, but did not meet the primary endpoint of clinical remission. 
    • “Though the results didn’t meet the mark statistically, Esi Lamousé-Smith, the company’s vice president of gastroenterology, said they were clinically meaningful. Data showed the drug was particularly effective in participants who had previously tried at least two medications, she added.”
  • BioPharma Dive notes,
    • “Cytokinetics said Tuesday that its drug Myqorzo succeeded in a Phase 3 trial in people with a progressive heart condition, opening up a sizable market opportunity and separating the treatment from a rival therapy marketed by Bristol Myers Squibb.
    • “According to Cytokinetics, Myqorzo met the dual main goals of a study in people with the “non-obstructive” form of hypertrophic cardiomyopathy, or HCM. When compared to a placebo, people receiving Myqorzo had a statistically significant improvement in peak oxygen consumption as well as scores on an assessment of heart health after 36 weeks. The drug also hit on key secondary measures, among them a commonly used evaluation of heart symptoms.
    • “Cytokinetics said no new safety signals were identified in the trial and that the percentage of patients completing treatment was similar between those getting Myqorzo or a placebo. Drops of over 50% in left ventricular “ejection fraction”— or the amount of blood pumped into the arteries, a known risk of drugs like Myqorzo — occurred in 27 treatment recipients, versus one in the placebo group. That side effect was associated with two cases of heart failure and led 3% of participants to interrupt treatment.”

From the U.S. healthcare business front,

  • The New York Times lets us know “there’s a right and wrong way to use urgent care.”
    • “We asked experts when you should use one, and when you’re better off visiting an ER or primary care doctor instead.”
  • Beckers Hospital Review tells us,
    • “Irving, Texas-based Christus Health took over operations May 1 at Mount Pleasant, Texas-based Titus Regional Medical Center, and renamed it Christus Health – Mount Pleasant Hospital, according to a May 1 release shared with Becker’s. 
    • “Christus Health was selected as the strategic partner for Titus Regional in early February after the board of managers for the 174-bed hospital voted to move forward with the transaction. 
    • “The acquisition is part of Christus Health’s broader expansion in the area. The system opened the Christus Health Mount Pleasant Emergency Care Center Feb. 9, a $33 million, 36,000-square-foot facility that also houses a multispecialty clinic, which opened April 13, and houses cardiology, gastroenterology, primary care, pulmonology, urology and more services.”
  • and
    • “As retailers, payers and drugmakers expand access to GLP-1 therapies — with companies like Amazon and Walmart launching weight management programs — the drug class is reshaping both care delivery and pharmaceutical investment strategies.
    • “That demand is influencing drug development, with obesity treatments overtaking oncology as the largest contributor to late-stage pipeline value for the first time in 16 years, according to a May 4 report from Deloitte.”
  • Fierce Pharm informs us,
    • “With a better-than-expected first quarter in the books, Pfizer—continuing to grapple with the post-pandemic overhang from its COVID-19 franchise—is sticking with the sales forecast it set earlier this year, raising questions from at least one analyst about whether it could have lifted its outlook.
    • “Buoyed by notable sales beats from blood thinner Eliquis, pneumococcal vaccine Prevnar and breast cancer medicine Ibrance, among others, Pfizer’s overall revenue in the first quarter grew 2% year over year on an operational basis to $14.5 billion. When excluding sales of its COVID-19 products Comirnaty and Paxlovid, the growth rate (PDF) was 7% for the period on an operational basis, the company said Tuesday.
    • “Pfizer’s “strong” performance across the board helped the company deliver first-quarter revenue about $641 million above consensus forecasts, according to a May 5 note from analysts at Citi. Pfizer is also demonstrating that its commercial portfolio can flourish beyond the historically mammoth sales of its COVID-19 vaccine and antiviral, the Citi team said, noting that the company’s crop of recent launches and acquired products—including Padcev, Nurtec and Lorbrena—grew 22% operationally for the quarter.”
  • Fierce Healthcare points out,
    • “CVS announced Tuesday it will expand its use of lower-cost biosimilars and transition to interchangeable alternatives for select brands, including Johnson & Johnson’s psoriasis drug Stelara.
    • “The change comes as CVS Caremark works to increase adoption of U.S. Food and Drug Administration approved biosimilars for its most common formularies. The update aligns with the company’s broader formulary strategy, emphasizing affordability, access and value.
    • “The changes will be effective July 1, the company said in the announcement. 
    • “Our formulary plays a critical role in addressing rising drug costs without compromising clinical quality,” said Joshua Fredell, CVS Health senior vice president, in a statement. “Expanding adoption of FDA-approved biosimilars allows us to deliver significant savings for clients while supporting broader, more affordable access to proven therapies.”
  • BioPharma Dive reports,
    • “Shares of Vertex Pharmaceuticals were little changed late Monday after the Boston-based biotechnology company reported its latest round of earnings.
    • “Vertex, which has ballooned to a roughly $110 billion value thanks to the market success of its cystic fibrosis medicines, recorded $3 billion in revenue across the first three months of the year. That total was just shy of Wall Street estimates, according to Evercore ISI analyst Cory Kasimov.
    • “The lion’s share of revenue again came from Trikafta, a three-in-one oral therapy that was approved in 2019 and has the potential to work in approximately 90% of cystic fibrosis patients. It generated $2.35 billion in the quarter, down 7% from the same period a year prior. Meanwhile, revenue from a successor drug called Alyftrek grew eightfold, to $424 million, which Kasimov argued “may potentially signal a healthy switch rate.”
  • MedTech Dive relates,
    • “Olympus is partnering with EndoRobotics to distribute the South Korea-based medical device manufacturer’s endoscopic robotic devices for gastroenterology.
    • “Olympus will exclusively distribute the technologies globally, beginning in the U.S., as part of its EndoTherapy portfolio, the Tokyo-based company said Monday in the announcement.
    • “The deal comes less than a year after Olympus entered into an agreement with investment firm Revival Healthcare Capital to found a company called Swan EndoSurgical for the purpose of co-developing a robotic platform for gastrointestinal treatment.”

Weekend update

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Mental health care, Obesity, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Both the Senate and the House of Representatives are on State/District work breaks this week.
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services has begun collecting private payor rate data through its Fee-for-Service Data Collection System Clinical Lab Fee Schedule Module. CMS has created a guide for hospital outreach laboratories to determine their applicable status. An FAQ on Protecting Access to Medicare Act reporting is also available, as well as a booklet on reporting scenarios and examples. Next, applicable laboratories must complete the registration process to access the module. Laboratories must then gather their data and complete submission by July 31.”
  • and
    • “The Centers for Medicare & Medicaid Services has opened registration for its seventh annual CMS & Health Level Seven International Fast Healthcare Interoperability Resources Connectathon from July 14-16. The free virtual event will involve health care interoperability leaders, implementers and innovators collaborating for hands-on testing and shared learning on how CMS policies and FHIR-based solutions are being operationalized in real-world systems. Registration will be open through June 30.”

From the Food and Drug Administration front,

  • The Hill reports,
    • Thousands of tins of infant formula have been recalled over a toxin that could lead to illness among babies who consume it, according to a notice posted by the U.S. Food and Drug Administration.
    • In the notice, shared Saturday [May 2], the FDA said a2 Milk Company of Colorado had issued a voluntary recall of three batches of its a2 Platinum Premium USA formula, advertised for children who are 12 months old and younger.
    • “Cereulide, a toxin created by some strains of the Bacillus cereus bacterium, was found to be present in the formula, the notice warns. The toxin, which is not eliminated even when the formula is prepared with hot water, can make infants sick within as little as 30 minutes.”
  • BioPharma Dive relates,
    • “The Food and Drug Administration on Friday approved a particular kind of protein-degrading medicine for the first time, green-lighting biotechnology firm Arvinas’ Veppanu for use in treating certain people with a common form of breast cancer.
    • “Formerly known as vepdegestrant, Veppanu is approved for a subgroup of adults whose metastatic, estrogen receptor-positive, HER2-negative breast cancer has progressed after at least one endocrine therapy. The clearance makes the treatment available specifically to people who fit that criteria and have mutations to a gene called ESR1.
    • “Veppanu is what’s called a “PROTAC,” or proteolysis-targeting chimera. The drug works by taking unwanted proteins — in Veppanu’s case, estrogen receptors — that are linked to disease and trashing them via the cell’s natural waste disposal system. Most approved medicines, by contrast, bind to a molecular target and block or amplify its activity.
    • “This milestone demonstrates that targeted protein degradation can translate into meaningful clinical impact,” said Arvinas CEO Randy Teel, in a statement.” 
  • The Wall Street Journal adds,
    • “British pharmaceutical group AstraZeneca AZN said it would continue to work with U.S. regulators on a review of its breast-cancer candidate after the drug failed to get backing at a key advisory committee vote.
    • “The Food and Drug Administration’s oncologic drugs advisory committee voted six to three against the benefit-risk profile of camizestrant, a candidate drug for the treatment of breast cancer, the FTSE 100-listed drugmaker said late Thursday [April 30].
    • “AstraZeneca will continue to work with the FDA as it completes its review of the application,” it said. The regulator isn’t bound by the committee’s guidance, but takes its advice into consideration.
    • “We strongly believe in the results of the Serena-6 trial [testing camizestrant], and are encouraged that the committee saw camizestrant as a safe and effective potential new medicine,” Astra’s Susan Galbraith said.”
  • Per Fierce Pharma tells us,
    • “AstraZeneca fared better during the second vote at its meeting with the FDA’s Oncologic Drugs Advisory Committee (ODAC) this week. 
    • “On Thursday [April 30], the panel of outside experts voted 7 to 1, with one abstention, in favor of AZ’s bid to propel a regimen of Truqap plus abiraterone (J&J’s Zytiga) and androgen deprivation therapy (ADT) toward approval in PTEN-deficient metastatic hormone-sensitive prostate cancer. 
    • “The committee was swayed on the regimen’s risk and benefit in part by data from AZ’s phase 3 CAPItello-281 trial, in which the Truqap combo helped slash the risk of radiographic disease progression or death by 19% and reached a 7.5-month improvement in median radiographic progression-free survival over a control of Zytiga and ADT.”
  • Per an FDA news release,
    • “Today [May 1], the U.S. Food and Drug Administration is announcing that it issued a “safe to proceed” letter to Revolution Medicines, allowing the sponsor to initiate an expanded access treatment protocol (EAP) for its experimental pancreatic cancer drug, daraxonrasib. 
    • “The expanded access treatment protocol is for patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). The FDA received the expanded access request from Revolution Medicines on April 28 and signed it on April 30.” * * *
    • “Granting the request two days after receiving the expanded access application reflects the FDA’s strong commitment to facilitate early access to therapies for serious and life-threatening conditions, including pancreatic cancer,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Having taken care of many patients with metastatic cancer, I am hopeful that today’s action will improve the lives of patients suffering from this disease.”
    • “Daraxonrasib is a RAS inhibitor designed to inhibit a protein (RAS) that is mutated in most pancreatic cancer tumors.” 

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced on May 1:
    • “As of May 1, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity started later than expected in most regions of the United States, though illness is not more severe compared with recent seasons. RSV activity has peaked in many regions of the country. This unusual timing means higher levels of RSV activity may continue into May for some regions.
    • “COVID-19 activity is low in most areas of the country.
    • “Seasonal influenza activity continues to decrease. Influenza A activity is low across all regions and influenza B activity continues to trend downward.”
  • The University of Minnesota’s CIDRAP adds,
    • Utah this week added 18 more measles cases to its 2026 tally, for a total of 428, while Arizona posted two new cases in its ongoing outbreak, for 93 so far this year, according to their respective state health departments. The outbreak in Utah is currently the largest in the nation.
    • “The nationwide measles infection total for the year to date stands at 1,814, up from 1,792 last week, the Centers for Disease Control and Prevention said today in its weekly update.
    • “Of the national total, 1,803 measles cases were reported by 37 states and New York City. The remaining 11 were diagnosed in international visitors to the United States. Since the beginning of the year, 24 new outbreaks have been noted, and 93% of cases are outbreak-associated (415 from outbreaks starting this year and 1,273 from those that began in 2025). In all of last year, 2,288 measles cases were confirmed. 
    • “This year, 51% of measles infections have occurred in children and adolescents aged 5 to 19 years, and 21% were diagnosed in those younger than 5 years. Among all patients, 92% were unvaccinated or had an unknown vaccination status, while 4% had received only one dose.”
  • The Wall Street Journal reports.
    • “We’ve built a world that can numb discomfort instantly, and we’re surprised we feel less alive. 
    • As artificial intelligence makes life frictionless, we risk removing the very frictions that keep human beings healthy: effort, challenge, learning and forward motion. The next public-health crisis may be stagnation, not stress. 
    • “The fix isn’t another pleasure. It’s progression.
    • “Progression is not simply about moving forward; nor is it about constant achievement or relentless productivity. It is about adaptation: the way a muscle grows stronger when challenged, or a mind becomes more flexible when it explores. 
    • “Progression is engaging in challenges that expand our future capacity—physically, behaviorally and mentally. When we do this consistently, as research conducted in my own labs (as well as many others) shows, we improve mood, strengthen resilience, enhance health and slow many processes associated with aging. 
    • “Humans thrive when they grow. This matters biologically.”
  • The Washington Post relates,
    • ‘For decades, a mysterious, two-lobed organ nestled behind the breastbone has been overlooked by most physicians, thought to be a largely useless lump for most of human life: the thymus.
    • “The ancient Greeks posited this knob of tissue might be the seat of the soul. In the early 1960s, a Nobel laureate dismissed it as a mere graveyard for cells, “an evolutionary accident of no very great significance.” Today, scientists know the thymus plays an essential role in setting up a functioning immune system in childhood, but then starts to rapidly shrink into obsolescence in puberty.
    • “Now, a raft of research is recasting the thymus from a bit player to a potent regulator of aging and immune health across the lifespan.
    • “Studies highlight the crucial role it might play in longevity, as well as protecting against cancer, autoimmune disease and cardiovascular risk. The work has ignited interest in finding ways to rejuvenate the thymus, slow its decay and better understand its function.
    • “It was completely assumed the thymus would become irrelevant,” said Hugo Aerts, director of the Artificial Intelligence in Medicine Program at Mass General Brigham. In studies published in Nature, Aerts and colleagues found that people with a healthier thymus were less likely to develop lung cancer or to die of heart disease — or any cause. They also responded better to cancer immunotherapy treatments.
    • “Key questions remain: Is the thymus the driver of these improved health outcomes or an indirect barometer of better overall health? Why does its decline vary between different people, and can that be slowed or stopped? And, perhaps most fundamentally, why did it take so long to reconsider the thymus?”
  • The New York Times points out “three medical routines that older people may not need>
    • “Some screenings and treatments no longer make sense for patients as they age. Researchers have just added a few more to the list.”
  • MedPage Today notes,
    • “Infection remains a top cause of maternal mortality with most infection-related maternal deaths being preventable, a descriptive study of Maternal Mortality Review Committee (MMRC) data found.
    • “Only half of moms who died from infection-related causes within 1 year of the end of pregnancy (51.5%) had confirmed receipt of antibiotics and only 11.8% had received antibiotics within the recommended 1 hour, reported Naima T. Joseph, MD, MPH, of Boston Medical Center and Boston University School of Medicine, in a presentation at the American College of Obstetricians and Gynecologistsopens in a new tab or window (ACOG) annual meeting.” * * *
    • “ACOG attendee Sophia Drosinos, MD, of Viva Eve in New York City, told MedPage Today that the findings were “gut wrenching.”
    • “Drosinos, who was not involved in the research, noted that “most hospitals now have some sort of sepsis protocols very early on in somebody’s presentation,” but that she hoped hopefully hospitals will include all of the strategies outlined in the study to decrease maternal mortality.”
  • Per a National Institutes of Health news release,
    • “A team of National Institutes of Health (NIH) scientists and international colleagues have reported the first evidence from a randomized controlled clinical trial indicating that a GLP-1 receptor agonist can reduce the days in which patients with obesity and alcohol use disorder engage in heavy drinking. Led by researchers at Copenhagen University Hospital, the new study adds to a growing body of evidence suggesting that GLP-1s could be useful in treating alcohol use disorder.
    • “Very few medications are currently approved for alcohol use disorder, and these are vastly underutilized. A new option that is more accessible and more effective could be a gamechanger for closing the treatment gap,” said Director of NIH’s National Institute on Alcohol Abuse and Alcoholism (NIAAA) George Koob, Ph.D., a study co-author.”
  • Medscape significantly adds,
    • “GLP-1 medications may cause slight muscle loss, but benefits outweigh concerns. Weight loss, whether through GLP-1s or lifestyle changes, can reduce muscle mass. Resistance training and adequate protein intake are recommended to mitigate muscle loss.”
  • Health Day lets us know,
    • “Higher intake of legumes and soy products is associated with fewer chronic obstructive pulmonary disease (COPD) symptoms among former smokers, according to a study published online Feb. 23 in Chronic Obstructive Pulmonary Diseases.”

From the U.S. healthcare business and artificial intelligence front,

  • The Wall Street Journal reports,
    • Eli Lilly LLY Chief Executive Dave Ricks was on stage with Nvidia NVDA founder Jensen Huang earlier this year in San Francisco touting the company’s tech prowess when Huang teased him about the painstaking process of developing new drugs.” 
    • “I’m really hoping that your industry moves from drug discovery which is kind of like wandering around the forest looking for truffles,” Huang said, in front of a crowd of biotech and pharma investors.
    • “Indeed, Ricks and the rest of the pharmaceutical industry are looking to expand beyond collecting soil samples and bark pieces to find new drugs and are instead turning their hopes—and investment dollars—to AI. Lilly first announced a partnership with chip-maker Nvidia in October to build what it called the industry’s most powerful supercomputer, and expanded that in January with a $1 billion, five-year collaboration mixing their scientists and engineers in a new Bay Area lab aimed at discovering new medicines with AI tools.
    • “They aren’t alone. Rival Roche has already announced it is building an even bigger supercomputer in partnership with Nvidia. Companies such as GSK, AstraZeneca and Merck have announced billions of dollars worth of partnerships in recent months with tech and AI-focused biotech companies aimed at fully exploiting AI.
  • BioPharma Dive relates,
    • “Moderna topped Wall Street analysts’ expectations in reporting higher-than-expected revenue in the first quarter, adding to an ongoing turnaround that’s helped the company nearly double its market value since late last year.  
    • “The vaccine maker reported first-quarter sales of $389 million, more than tripling its total during the same period a year ago — a surge primarily fueled by international sales of its COVID-19 vaccine. The company did, however, report a net loss of $1.3 billion, about $1 billion more than a year ago, due to charges related to a litigation settlement with Arbutus Biopharma and Genevant Sciences.”
  • Fierce Pharma tells us,
    • “Shortly after laying out $75 million upfront for Corstasis Therapeutics and its congestive heart failure edema drug Enbumyst, Esperion Therapeutics is itself being acquired and taken private by healthcare investment firm Archimed. 
    • “On Friday, the companies announced that Archimed will pay $3.16 per share for Esperion at closing on May 1, alongside a potential CVR sweetener of contingent milestone payments tied to the future sales performance of Esperion’s Nexletol, Nexlizet and Enbumyst that could reach up to $100 million. 
    • “All told, the deal could be worth up to $1.1 billion, assuming those commercial milestones are met, the companies said in a release. The upfront consideration from Archimed marks a 58% premium on Esperion’s closing share price on April 30.” 
  • Fierce Healthcare informs us,
    • “Omada Health has signed on with Optum Rx to participate in its Weight Engage program, furthering the company’s ability to scale its offerings to reach more people who need cardiometabolic care and support.
    • “The pharmacy benefit management giant—which is one of the industry’s Big Three firms—launched the program in response to the demand for GLP-1s, as patients seeking these drugs face spotty coverage and often a thicket of barriers in the way.
    • “Optum said in a post that adherence can also be a challenge, as some patients may face uncomfortable side effects, or may be unresponsive to the medications. That makes having a more holistic, wrap-around model in place to support their journey crucial, the PBM said.
    • “That’s where Omada comes in. Optum is also working with Calibrate and Virta Health under the program, per the announcement.”
  • Medscape notes,
    • “The rapid rise of GLP-1 medications, coupled with declining rates of bariatric surgery, is causing a notable shift in obesity care. Rather than shuttering, however, bariatric surgery practices are choosing to reshape and expand their offerings. 
    • “Private practices and hospital-based bariatric centers alike are broadening their offerings to include not only surgery but also GLP-1 therapies and other medical treatments, along with psychological support, nutrition services, and, in some cases, body contouring procedures to address post-weight loss concerns.
    • “The goal, those involved said, is to create a one-stop center for obesity care, reflecting a growing, research-driven understanding that optimal management does not pit surgical against medical treatments but often requires both to address a lifelong chronic disease.”
  • Beckers Hospital Reviews seeks to share Mark Cuban’s playbook with readers.

Notable Death

  • Genetic Engineering and Biotechnology News reports,
    • “J. Craig Venter, PhD, the founder, board chair, and CEO of the J. Craig Venter Institute (JCVI) has died in San Diego following a brief hospitalization for unexpected side effects that arose from the treatment of a recently diagnosed cancer, reported the JCVI in a press statement.
    • “Venter helped define modern genomics and launch the field of synthetic biology. He was skillful in building interdisciplinary teams, pushing for new ideas and faster methods, and insisting that discovery should translate into real-world impact. He was also a major advocate for strong federal science funding and for partnerships that accelerate progress across government, academia, and industry.”
    • “Craig believed that science moves forward when people are willing to think differently, move decisively, and build what doesn’t yet exist,” said Anders Dale, PhD, president of JCVI. “His leadership and vision reshaped genomics and helped ignite synthetic biology. We will honor his legacy by continuing the mission he built—advancing genomic science, championing the public investments that make discovery possible, and partnering broadly to turn knowledge into impact.”
    • “Venter has been recognized as an essential force in the impetus to evolve genomics from a slow, academic discipline into a fast-moving, data-driven, and commercially relevant enterprise, leaving a lasting imprint on biotechnology, medicine, and synthetic biology,” says John Sterling, GEN’s Editor in Chief, who has known and worked editorially with Venter over the past 35 years.
    • “Venter was controversial and often challenged the scientific orthodoxy, with critics accusing him of hype and going overboard on privatization. To many, he was a visionary focusing on technological acceleration and blending academic science with the zeal of an entrepreneur. Supporters saw him as a pioneer who sped up genomics by years.”
  • Mr. Ventner was 79 years old at the time of his death. RIP.